HYDROXYBUTYRATE DEHYDROGENASE REAGENT
FDA 510(k) clearance K834084 · decided 1984-02-04
Clearance details
- K-number
- K834084
- Device name
- HYDROXYBUTYRATE DEHYDROGENASE REAGENT
- Applicant
- Sterling Biochemical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-28
- Decision date
- 1984-02-04
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- JKF
- Device class
- 1
- Regulation number
- 862.1380
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, 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 |
|---|---|---|
| HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET (K861855) | Sterling Diagnostics, Inc. | 1986-06-16 |
Recalls involving this device
No recalls on record reference this clearance.