TB SUSCEPTIBILITY QUADS I AND II
FDA 510(k) clearance K920143 · decided 1992-06-09
Clearance details
- K-number
- K920143
- Device name
- TB SUSCEPTIBILITY QUADS I AND II
- Applicant
- Remel Co.
- Decision
- Substantially Equivalent
- Date received
- 1992-01-13
- Decision date
- 1992-06-09
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- MJD
- Device class
- 2
- Regulation number
- 866.1700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Lenexa, KS, 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 |
|---|---|---|
| NIACIN REAGENT STRIP (K840981) | Remel Co. | 1984-03-23 |
| 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.