AK AGAR 2
FDA 510(k) clearance K833207 · decided 1983-10-27
Clearance details
- K-number
- K833207
- Device name
- AK AGAR 2
- Applicant
- Acumedia Manufacturers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-19
- Decision date
- 1983-10-27
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- LKA
- 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 |
|---|---|---|
| IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT (K872687) | I.A.F. Production, Inc. | 1987-08-11 |
| IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD (K872688) | I.A.F. Production, Inc. | 1987-08-11 |
| IAFP MUELLER HINTON AGAR (K872686) | I.A.F. Production, Inc. | 1987-08-11 |
| YEAST BEEF AGAR-ANTIBIOTIC MED.4 (K833218) | Acumedia Manufacturers, Inc. | 1983-10-27 |
Recalls involving this device
No recalls on record reference this clearance.