SIGMA BUN REAGENT
FDA 510(k) clearance K933679 · decided 1993-12-17
Clearance details
- K-number
- K933679
- Device name
- SIGMA BUN REAGENT
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-28
- Decision date
- 1993-12-17
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- LFP
- Device class
- 2
- Regulation number
- 862.1770
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GAMBRO DQM 200 (K990039) | Gambro Healthcare | 2000-01-27 |
| HICHEM BUN REAGENT (K992847) | Elan Holdings, Inc. | 1999-10-14 |
| SIGMA DIAGNOSTICS BUN REAGENT (K963537) | Sigma Diagnostics, Inc. | 1996-10-24 |
| BUN REAGENT KIT (K873132) | A-Kem, Inc. | 1987-10-23 |
| LIQUILYME BUN REAGENT (K812945) | Amresco, Inc. | 1981-11-06 |
Recalls involving this device
No recalls on record reference this clearance.