Atlas FDA

Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
HDL EX-SEP PRECIPITATING REAGENT (K833431)Preventive Diagnostics Corp.1984-01-13
TECH. RA-1000 SYS SERUM CHLORIDE (K833746)Technicon Instruments Corp.1984-01-13
OMNI-FAL I & II (K833009)American Monitor Corp.1984-01-13
TOTAL PROTEIN REAGENT CS-724 (K833950)Fisher Scientific Co., LLC1984-01-13
LH RIA (K833854)Syncor Intl. Corp.1984-01-13
ALBUMIN REAGENT CS-716 (K833699)Fisher Scientific Co., LLC1984-01-13
ALKALINE PHOSPHATASE-RATE (K833744)Seragen Diagnostics, Inc.1984-01-13
SHABAN 9865 IL#78637 JUNCTION BLOC (K833804)Shaban Mfg. Co.1984-01-13
TRI-LEVEL BILIRUBIN CONTROLS (K833898)Sandare Chemical Co., Inc.1984-01-13
UR/RITE SYSTEM (K833666)Wright Laboratories, Inc.1984-01-13
UREA NITROGEN-UV (K833931)Seragen Diagnostics, Inc.1984-01-13
IL MODEL 840 MICROPROCESSOR LOADER (K833505)Instrumentation Laboratory CO1984-01-11
REAGENT TESTS STRIP COMBINATIONS (K833521)Syn-Kit, Inc.1984-01-11
DIRIA-PROGK IMMUNOASSAY (K832694)Sorin Biomedica, Fiat, USA, Inc.1984-01-11
STRIP SPLITTER II -HALF WIDTH CARRIER (K834150)Larken Industries, Inc.1984-01-11
HOSPITAL LAB IN-HOME EARLY PREG TEST (K832593)Aicl-Pack, Inc.1984-01-11
ADRENOCOR TICOTROPIC HORMONE RADIOIMM (K833471)Nichols Institute Diagnostics1984-01-11
CHEM TRAK LIQUID BILIRUBIN CONTROL (K833097)Medical Analysis Systems, Inc.1984-01-11
ATAC 3000 (K832115)Turpen Laboratory Systems, Inc.1984-01-10
PREGNASTICK URINE HCG KIT (K833504)Monoclonal Antibodies, Inc.1984-01-09
RIACOAT T-4 (K833745)Immuno Assay Corp.1984-01-04
TITANGEL HIGH RESOLUTION CONTROL (K833639)Helena Laboratories1984-01-04
ACA THYROXINE UPTAKE CALIBRATOR (K833702)E.I. Dupont DE Nemours & Co., Inc.1984-01-04
SERUM THYROTROPIN ASSAY KIT, TIPSEP- (K833713)Nuclear Diagnostics, Inc.1983-12-29
QEA SODIUM/POTASSIUM ANALYZER (K833776)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-12-29
C. PTH RADIOIMMUNOASSAY KIT-CPTHK (K833768)Sorin Biomedica, Fiat, USA, Inc.1983-12-29
POTASSIUM SODIUM ANALYSIS PRODUCTS (K833535)Shaban Mfg. Co.1983-12-29
SYVA ADVANCE CORTISOL ASSAY (K833932)Syva Co.1983-12-29
PARTIAL PRESSURE ELECTRODE MEASUREMENT (K833536)Shaban Mfg. Co.1983-12-29
PARTIAL PRESSURE ELECTRODE MEASUREMENT (K833534)Shaban Mfg. Co.1983-12-29
ENZYMATIC CO2 (K833724)American Monitor Corp.1983-12-29
FLOW-PAC GGT REAGENT SET (K833029)American Research Products Co.1983-12-29
ACA THYROXINE CALIBRATOR (K833700)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
IRI SPEC URINALYSIS CONTROL (K832713)Intl. Remote Imaging Systems1983-12-22
EPOS CHEMISTRY ANALYZER 5060 & 6410 (K833448)Emd Chemicals, Inc.1983-12-22
ACLAIM-QAP IBM PERSONAL COMPUTER EDT (K833353)American Dade1983-12-22
CYSTINE TRYPTIC MEDIUM (K834007)Micro Media Laboratories1983-12-22
RIANEN LUTEINIZING HORMONE RIA KIT (K833376)New England Nuclear1983-12-20
N-ACETYLPROCAINAMIDE CALIBRATOR (K833385)E.I. Dupont DE Nemours & Co., Inc.1983-12-16
PHOTOMETER LP 300 (K832531)Dr. Bruno Lange GmbH1983-12-12
ARTERIAL MICRO COLLECTION KIT (K833312)Current Technologies, Inc.1983-12-08
AMBERLITE CG50 RESIN, 100-200 MESH (K833320)Biosan Laboratories, Inc.1983-12-08
NORMAL URINE CONTROL (K833192)Biosan Laboratories, Inc.1983-12-08
ABNORMAL URINE CONTROL (K833191)Biosan Laboratories, Inc.1983-12-08
VENTREZYME EIA CONTROLS-IMMUNOASSAY (K833423)Ventrex Laboratories, Inc.1983-12-08
LANCER ANALYZER CUPS (K833157)Sherwood Medical Co.1983-12-08
NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM (K833154)Nova Biomedical Corp.1983-12-08
WAKO GLUCOSE C (K833257)Wako Chemicals USA, Inc.1983-12-08
DIAGNON B12 57CO RIA KIT (K832717)Diagnon Corp.1983-12-08
FLAME PHOTOMETER T281-T282-T283 (K832886)Texas Intl. Laboratories, Inc.1983-12-08
CAPIJECT SYS CAPILLARY BLOOD COLLECT (K833475)Terumo Medical Corp.1983-12-08
OREIA II B-HCG, ENZYME INNUNOASSAY (K832801)Organon, Inc.1983-12-08
IMPACT 400 #1447X2 (K833067)Gilford1983-12-08
MICRO-SAMPLE OSMOMETER 3M0 (K832783)Advanced Instruments, Inc.1983-11-28
AQUEOUS BLOOD GAS CONTROL (K833146)Bionostics, Inc.1983-11-28
QUIDEL HCG ENZYME IMMUNOASSAY KIT (K833156)Quidel Corp.1983-11-25
NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU (K833153)Nova Biomedical Corp.1983-11-25
AMYLASE (K832889)Pointe Scientific, Inc.,1983-11-25
EARLY PREGNANCY DETECTION TEST KIT (K833466)Quidel Corp.1983-11-25
DUPONT LINEARIZATION MODULE (K832746)E.I. Dupont DE Nemours & Co., Inc.1983-11-25
REAGENT SET TRIGLYCERIDES GPO (K833082)Boehringer Mannheim Corp.1983-11-25
POTASSIUM ELECTRODE TIP ASSAMBLY-K- (K833159)Hi Chem, Inc.1983-11-25
REPORTING INTEGRATOR 3392A (K833113)Hewlett-Packard Co.1983-11-21
TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 (K833129)Tago, Inc.1983-11-21
BETA SCAN REAGENT STRIP (K832691)Orange Medical Instruments, Inc.1983-11-14
PARAMAX BILIRUBIN CALIBRATORS (K833005)American Dade1983-11-14
TECHNICON RA-1000 SYS-ISE MODULE & (K833072)Technicon Instruments Corp.1983-11-14
FLOW-PAC SODIUM REAGENT SET (K833036)American Research Products Co.1983-11-07
TDX GLUCOSE (K833069)Abbott Laboratories1983-11-07
TOTAL & DIRECT BILIRUBIN PROCEDURES (K832942)Sandare Chemical Co., Inc.1983-11-07
SPIRIT CHEMISTRY SYSTEM (K833116)Baker Instructions Corp.1983-11-07
SHOT GUN KIT FOR CK-MB (K831391)Serapine Corp.1983-11-04
PREGNA-TEC (K832918)Medilab Corp.1983-11-03
BIO-REX 70 RESIN 100-200 MESH PH6.2 (K833319)Biosan Laboratories, Inc.1983-11-03
STARLYTE (K832744)Electro-Nucleonics Laboratories, Inc.1983-11-03
CALCIUM DYE REAGENT-CS-718-A/BUFFER (K833035)Fisher Scientific Co., LLC1983-11-03
TECHNICON RA-1000 SYSTEM (K833023)Technicon Instruments Corp.1983-11-03
SERUM IRON & TIBC#65084 & 65085 (K833017)Emd Chemicals, Inc.1983-11-03
GLUCOKEY (K831194)Ulster Scientific, Inc.1983-10-31
TANDEM-E THYROID STIMULATING HORMONE KIT (K832813)Hybritech, Inc.1983-10-31
BUN LIQUID STABLE REAGENT SET (K832941)Medical Analysis Systems, Inc.1983-10-28
ENZYMATIC GLUCOSE DETERMINATION (K832926)Seragen Diagnostics, Inc.1983-10-28
PROCEDURE 460 FOR DETERM. OF CHLORIDE (K833166)Sigma Chemical Co.1983-10-28
MODIFIED CHORIO-SHURE (K832892)Nuclear Medical Laboratories, Inc.1983-10-28
ELECTRODES FOR BLOOD GAS ANALYZERS (K832981)Analytical Products, Inc.1983-10-28
GAS CHROMATOGRAPH 5890A (K832962)Hewlett-Packard Co.1983-10-28
B-SLIDE PREGNATE PREGNANCY TEST KIT (K832879)Fisher Scientific Co., LLC1983-10-28
COAT-A-COUNT FREE T3 RIA KIT (K832164)Diagnostic Products Corp.1983-10-27
ACCU-PREP PROGRAMMABLE AUTO-DILUTER (K832809)Beckman Instruments, Inc.1983-10-27
QUANTAPHASE B-12-COBALMIN-FOLATE- (K833247)Bio-Rad1983-10-19
FLOW-PAC SHOLESTEROL REAGENT SET (K832780)American Research Products Co.1983-10-14
HEXOKINASE, GLUCOSE (K832872)Pointe Scientific, Inc.,1983-10-14
SERAYZER ALT/SGPT REAGENT STRIPS (K832791)Miles Laboratories, Inc.1983-10-14
SHABAN #9868 TUBING KIT-9870 STYLET (K832937)Shaban Mfg. Co.1983-10-14
PARAMAX PHOSPHORUS REAGENT (K833002)American Dade1983-10-14
PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS (K832708)American Dade1983-10-14
RIA SOFTWARE (K832760)Kemble Instruments, Inc.1983-10-14
SHABAN #9858 ASPIRATOR ASSEMBLE #9862- (K832932)Shaban Mfg. Co.1983-10-14
TOTAL IRON-BINDING CAPACITY ACCESORY (K832759)Seragen Diagnostics, Inc.1983-10-14
PARAMAX & GLUTAMYTRANSFERASE REAGENT (K833001)American Dade1983-10-14
← Previous Next →

Track Clinical Chemistry automatically

Every clearance here is in the API, with alerts when new ones post.