MIDDLEBROOK 7H10 AGAR BASE-LOWPH
FDA 510(k) clearance K823859 · decided 1983-03-08
Clearance details
- K-number
- K823859
- Device name
- MIDDLEBROOK 7H10 AGAR BASE-LOWPH
- Applicant
- Gibco Laboratories Life Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-22
- Decision date
- 1983-03-08
- Days to decision
- 76 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
+ Add to Predicate Builder ◉ Watch Gibco Laboratories Life Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| NIACIN REAGENT STRIP (K840981) | Remel Co. | 1984-03-23 |
Recalls involving this device
No recalls on record reference this clearance.