HICHEM BUN REAGENT
FDA 510(k) clearance K992847 · decided 1999-10-14
Clearance details
- K-number
- K992847
- Device name
- HICHEM BUN REAGENT
- Applicant
- Elan Holdings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-08-24
- Decision date
- 1999-10-14
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- LFP
- Device class
- 2
- Regulation number
- 862.1770
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Brea, CA, 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 |
| SIGMA DIAGNOSTICS BUN REAGENT (K963537) | Sigma Diagnostics, Inc. | 1996-10-24 |
| SIGMA BUN REAGENT (K933679) | Sigma Chemical Co. | 1993-12-17 |
| 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.