DERMATOPHYTE TEST MEDIUM
FDA 510(k) clearance K870637 · decided 1987-04-14
Clearance details
- K-number
- K870637
- Device name
- DERMATOPHYTE TEST MEDIUM
- Applicant
- Hardy Media
- Decision
- Substantially Equivalent
- Date received
- 1987-02-13
- Decision date
- 1987-04-14
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- JSJ
- Device class
- 1
- Regulation number
- 866.2360
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Santa Barbara, CA, 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 |
|---|---|---|
| POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (K882463) | Lakewood Biochemical Co., Inc. | 1988-06-22 |
| SABOURAUD MALTOSE AGAR (K881570) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| YM BROTH (K881571) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MYCOLOGICAL AGAR W/LOW PH (K881549) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| CHAPMAN STONE MEDIUM (K881526) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PHYTONE YEAST EXTRACT AGAR (K881573) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| STREPTOSEL (K881578) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| BRILLIANT GREEN AGAR W/SULFADIAZINE (K881530) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| INHIBITORY MOLD AGAR (K881565) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MITIS SALIVARIUS AGAR (K881547) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TERGITOL 7 BROTH (K881561) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| LITTMAN AGAR (K881544) | Acumedia Manufacturers, Inc. | 1988-04-18 |
Recalls involving this device
No recalls on record reference this clearance.