HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)
FDA 510(k) clearance K902155 · decided 1990-06-12
Clearance details
- K-number
- K902155
- Device name
- HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)
- Applicant
- Hichem Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1990-05-15
- Decision date
- 1990-06-12
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- JIM
- Device class
- 2
- Regulation number
- 862.1340
- 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 |
|---|---|---|
| CHEMTAB (K790772) | Boehringer Mannheim Corp. | 1979-06-15 |
Recalls involving this device
No recalls on record reference this clearance.