NIACIN REAGENT STRIP
FDA 510(k) clearance K840981 · decided 1984-03-23
Clearance details
- K-number
- K840981
- Device name
- NIACIN REAGENT STRIP
- Applicant
- Remel Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-03-06
- Decision date
- 1984-03-23
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- MJD
- Device class
- 2
- Regulation number
- 866.1700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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 |
|---|---|---|
| TB SUSCEPTIBILITY QUADS I AND II (K920143) | Remel Co. | 1992-06-09 |
| MIDDLEBROOK 7H10 AGAR BASE-LOWPH (K823859) | Gibco Laboratories Life Technologies, Inc. | 1983-03-08 |
Recalls involving this device
No recalls on record reference this clearance.