BUN-REATIVE
FDA 510(k) clearance K760430 · decided 1976-11-01
Clearance details
- K-number
- K760430
- Device name
- BUN-REATIVE
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-08-13
- Decision date
- 1976-11-01
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- CDS
- Device class
- 2
- Regulation number
- 862.1770
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boehringer Mannheim Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test (K171247) | Epocal, Inc. | 2018-01-17 |
| BUN REAGENT (K040973) | Genchem, Inc. | 2004-12-27 |
| BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT (K033056) | Diamond Diagnostics, Inc. | 2004-01-30 |
| HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 (K925550) | Hichem Diagnostics | 1993-04-20 |
| BLOOD UREA NITROGEN (BUN) TESTCARD (K860543) | Ilex Corp. | 1986-04-21 |
| CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS (K855091) | Sen Tech Medical Corp. | 1986-03-14 |
| LANCER BUN RATE REAGENT KIT (K812308) | Sherwood Medical Co. | 1981-08-31 |
| BUN RATE REAGENT (K811193) | Chem-Elec, Inc. | 1981-07-10 |
| BUN REAGENT KIT #88108 (K800616) | Hi Chem, Inc. | 1980-04-10 |
| BUN KIT (K800590) | Nobel Scientific Industries, Inc. | 1980-04-04 |
| BUN REAGENT KIT (K800071) | Fisher Scientific Co., LLC | 1980-02-05 |
| FERMCOTEST R BUN RATE REAGENT TEST KIT (K791018) | Fermco Biochemics, Inc. | 1979-07-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |