INDICARD TEST
FDA 510(k) clearance K964015 · decided 1997-06-19
Clearance details
- K-number
- K964015
- Device name
- INDICARD TEST
- Applicant
- Litmus Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-07
- Decision date
- 1997-06-19
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- MJM
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Front Royal, VA, 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 |
|---|---|---|
| AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS (K923133) | Microprobe Corp. | 1992-09-25 |
Recalls involving this device
No recalls on record reference this clearance.