Boehringer Mannheim Corp.
340 FDA 510(k) clearances · Manufacturer
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| Record | Firm | Date |
|---|---|---|
| URIC ACID PAP (K895665) | Boehringer Mannheim Corp. | 1989-10-23 |
| CK-MB/LD-1 CONTROL SYSTEM (K894207) | Boehringer Mannheim Corp. | 1989-08-28 |
| PANCREATIC A-AMYLASE PNP (K892848) | Boehringer Mannheim Corp. | 1989-07-20 |
| IRON SYSTEM PACK REAGENTS (K892838) | Boehringer Mannheim Corp. | 1989-06-16 |
| BICARBONATE; SYSTEM PACK REAGENTS (K891991) | Boehringer Mannheim Corp. | 1989-06-09 |
| -AMYLASE EPS (K882225) | Boehringer Mannheim Corp. | 1989-01-03 |
| ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM (K883817) | Boehringer Mannheim Corp. | 1988-12-09 |
| TRACER(TM) II BLOOD GLUCOSE SYSTEM (K881908) | Boehringer Mannheim Corp. | 1988-07-12 |
| BUN (KINETIC) (K881677) | Boehringer Mannheim Corp. | 1988-06-07 |
| TOTAL IRON BINDING CAPACITY (TIBC) (K880546) | Boehringer Mannheim Corp. | 1988-03-24 |
| UNIMETER CALIBRATION KIT (K880610) | Boehringer Mannheim Corp. | 1988-03-24 |
| PYRIDOXAL-5-PHOSPHATE TABLETS (K874835) | Boehringer Mannheim Corp. | 1988-01-21 |
| REFLOTRON (R) AMYLASE (K874704) | Boehringer Mannheim Corp. | 1988-01-05 |
| REFLOTRON BILIRUBIN (K872818) | Boehringer Mannheim Corp. | 1987-11-23 |
| BICARBONATE (K874435) | Boehringer Mannheim Corp. | 1987-11-23 |
| PRECINORM L (K874230) | Boehringer Mannheim Corp. | 1987-11-23 |
| URIC ACID PAP (K873363) | Boehringer Mannheim Corp. | 1987-10-19 |
| TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL (K873049) | Boehringer Mannheim Corp. | 1987-08-28 |
| SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA) (K872306) | Boehringer Mannheim Corp. | 1987-08-18 |
| HITACHI 717 CHEMISTRY ANALYZER (K872494) | Boehringer Mannheim Corp. | 1987-07-09 |
| TINA-QUANT [A] CRP (K871895) | Boehringer Mannheim Corp. | 1987-06-15 |
| TINA-QUANT [A] TRANSFERRIN (K871896) | Boehringer Mannheim Corp. | 1987-06-15 |
| SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) (K871811) | Boehringer Mannheim Corp. | 1987-05-26 |
| PRECINORM(R) PROTEIN (K871027) | Boehringer Mannheim Corp. | 1987-05-15 |
| PRECIMAT(R) C3 (K871024) | Boehringer Mannheim Corp. | 1987-05-15 |
| PRECIMAT(R) TRANSFERRIN (K871022) | Boehringer Mannheim Corp. | 1987-05-14 |
| PRECIMAT(R) C4 (K871023) | Boehringer Mannheim Corp. | 1987-05-14 |
| PRECIMAT(R) CRP (K871055) | Boehringer Mannheim Corp. | 1987-05-06 |
| MODIFICATION OF ACCU-CHEK II (K863481) | Boehringer Mannheim Corp. | 1987-04-07 |
| TINA-QUANT(R) (A) C4 (K870931) | Boehringer Mannheim Corp. | 1987-03-24 |
| TINA-QUANT(R) (A) C3 (K870930) | Boehringer Mannheim Corp. | 1987-03-24 |
| ISE COMPENSATION SERA (K870379) | Boehringer Mannheim Corp. | 1987-02-26 |
| REFLOTRON(R) AST (GOT) (K870246) | Boehringer Mannheim Corp. | 1987-02-18 |
| TRACKER SYSTEM (K860948) | Boehringer Mannheim Corp. | 1986-12-08 |
| REFLOTRON(R) ALT (GPT) (K864082) | Boehringer Mannheim Corp. | 1986-12-04 |
| ENZYMUN-TEST(R) IGE (K863822) | Boehringer Mannheim Corp. | 1986-10-29 |
| PRECIMAT (R) IGA, G, M (K863352) | Boehringer Mannheim Corp. | 1986-09-17 |
| TINA-QUANT(R) IGM (K862762) | Boehringer Mannheim Corp. | 1986-09-08 |
| TINA-QUANT(R) IGA (K862763) | Boehringer Mannheim Corp. | 1986-09-04 |
| TINA-QUANT(R) IGG (K862764) | Boehringer Mannheim Corp. | 1986-09-03 |
| ENZYMUN-TEST HCG (K862108) | Boehringer Mannheim Corp. | 1986-08-19 |
| TWIN GOT-AST IFCC/GPT-ALT IFCC (K861792) | Boehringer Mannheim Corp. | 1986-07-29 |
| REFLOTRON URIC ACID (K861831) | Boehringer Mannheim Corp. | 1986-07-11 |
| ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704 (K861696) | Boehringer Mannheim Corp. | 1986-07-01 |
| ENZYMUN TEST TBG (K862109) | Boehringer Mannheim Corp. | 1986-06-30 |
| TWIN TRIGLYCERIDES GPO/CHOLESTEROL (K861793) | Boehringer Mannheim Corp. | 1986-06-27 |
| TWIN BUN/GLUCOSE (K861775) | Boehringer Mannheim Corp. | 1986-06-27 |
| HITACHI 736 (K860748) | Boehringer Mannheim Corp. | 1986-04-17 |
| ES600 IMMUNOASSAY SYSTEM (K860647) | Boehringer Mannheim Corp. | 1986-04-17 |
| PRECINORM IM AND PRECIPATH IM (K860970) | Boehringer Mannheim Corp. | 1986-04-03 |
| ENZYMUN-TEST FERRITIN (K860137) | Boehringer Mannheim Corp. | 1986-03-28 |
| CREATININE PAP (K854766) | Boehringer Mannheim Corp. | 1986-01-17 |
| ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL (K855225) | Boehringer Mannheim Corp. | 1986-01-17 |
| ES 22 (K854243) | Boehringer Mannheim Corp. | 1985-11-19 |
| IRON (K854298) | Boehringer Mannheim Corp. | 1985-11-12 |
| HITACHI 704 (K854025) | Boehringer Mannheim Corp. | 1985-10-28 |
| REFLOTRON SYSTEM (K852133) | Boehringer Mannheim Corp. | 1985-09-16 |
| ACCU-CHEK II (K851456) | Boehringer Mannheim Corp. | 1985-08-01 |
| PRECINORM HB (K852136) | Boehringer Mannheim Corp. | 1985-07-05 |
| UROTRON RL9 (K850348) | Boehringer Mannheim Corp. | 1985-03-12 |
| PERIDOCHROM TRIGLYCERIDES GPO (K850667) | Boehringer Mannheim Corp. | 1985-03-11 |
| PRECINORM H & PRECIPATH H (K850017) | Boehringer Mannheim Corp. | 1985-03-05 |
| CALCIUM (K850281) | Boehringer Mannheim Corp. | 1985-02-06 |
| ALBUMIN BCP (K844426) | Boehringer Mannheim Corp. | 1985-01-07 |
| PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE (K844655) | Boehringer Mannheim Corp. | 1985-01-07 |
| 80 MG/DL GLUCOSE CONTROL (K844581) | Boehringer Mannheim Corp. | 1984-12-12 |
| BOEHRINGER MANNHEIM DIAGNOSTICS ADAM (K843283) | Boehringer Mannheim Corp. | 1984-10-05 |
| PRECISET AMMONIA (K843569) | Boehringer Mannheim Corp. | 1984-09-28 |
| UNIVERSAL 2 S CENTRIFUGE (K843087) | Boehringer Mannheim Corp. | 1984-08-29 |
| EBA 3 S CENTRIFUGE (K843088) | Boehringer Mannheim Corp. | 1984-08-29 |
| BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE (K842393) | Boehringer Mannheim Corp. | 1984-08-16 |
| REFLOCHECK-S (K840962) | Boehringer Mannheim Corp. | 1984-06-22 |
| REFLOCHECK & GLUCOSE TEST STRIP SYS (K834271) | Boehringer Mannheim Corp. | 1984-02-13 |
| REAGENT SET TRIGLYCERIDES GPO (K833082) | Boehringer Mannheim Corp. | 1983-11-25 |
| SPIROMETER ISOLATION VALVE #8890 (K833088) | Boehringer Mannheim Corp. | 1983-10-28 |
| PRECISET CHOLESTEROL HIGH PERFORM (K832251) | Boehringer Mannheim Corp. | 1983-08-24 |
| CHOLESTEROL HIGH PERFORMANCE-K (K832158) | Boehringer Mannheim Corp. | 1983-08-16 |
| TITANIUM M.E. MULLER TYPE TOTAL HIP (K830356) | Boehringer Mannheim Corp. | 1983-03-09 |
| SINGLE VIAL AMYLASE PNP TEST (K823462) | Boehringer Mannheim Corp. | 1982-12-28 |
| CHOLESTEROL CHOD-PAP TEST (K823302) | Boehringer Mannheim Corp. | 1982-12-09 |
| SPECIAL CONTROL SERUM FOR HDL-CHOLES (K823196) | Boehringer Mannheim Corp. | 1982-11-29 |
| DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI (K823213) | Boehringer Mannheim Corp. | 1982-11-22 |
| BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA (K823087) | Boehringer Mannheim Corp. | 1982-11-18 |
| UNIMETER 330K (K822441) | Boehringer Mannheim Corp. | 1982-10-08 |
| HCT CENTRIFUGE (K822445) | Boehringer Mannheim Corp. | 1982-09-14 |
| PYRIDOXAL-5-PHOSPHATE STRIPES (K821805) | Boehringer Mannheim Corp. | 1982-07-02 |
| DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT (K821852) | Boehringer Mannheim Corp. | 1982-07-02 |
| 8700 CLINICAL CHEM. ANALYZER (K820888) | Boehringer Mannheim Corp. | 1982-05-14 |
| CYANMETHEMOGLOBIN TEST (K820596) | Boehringer Mannheim Corp. | 1982-03-26 |
| LD-L TRIS SYSTEM PACK TEST (K820378) | Boehringer Mannheim Corp. | 1982-03-08 |
| ELECTROLYTE ANALYZER ACCESSORY (K820118) | Boehringer Mannheim Corp. | 1982-02-04 |
| URIC ACID SYSTEM PACK TEST (K812978) | Boehringer Mannheim Corp. | 1981-11-06 |
| GLUCOSE-HK SYSTEM PACK TEST (K812303) | Boehringer Mannheim Corp. | 1981-09-01 |
| ENXYMATIC CREATININE TEST (K812095) | Boehringer Mannheim Corp. | 1981-08-31 |
| FUN-UV SYSTEM PACK TEST (K812290) | Boehringer Mannheim Corp. | 1981-08-31 |
| HITACHI 705 CALIBRATOR (K811921) | Boehringer Mannheim Corp. | 1981-07-23 |
| PRECINORM U & PRECIPATH U HUMAN SERUM (K811832) | Boehringer Mannheim Corp. | 1981-07-15 |
| REAGENT SET TRIGLYCERIDES (K811553) | Boehringer Mannheim Corp. | 1981-06-18 |
| HITACHI 705 AUTOMATIC BLOOD CHEMISTRY (K811194) | Boehringer Mannheim Corp. | 1981-05-27 |
| BIO SET TM SUBSTRATE CALIBRATORS (K810963) | Boehringer Mannheim Corp. | 1981-04-17 |
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