YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN
FDA 510(k) clearance K872700 · decided 1987-10-15
Clearance details
- K-number
- K872700
- Device name
- YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN
- Applicant
- Sita, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-07
- Decision date
- 1987-10-15
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- GPW
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Allentown, NJ, 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 |
|---|---|---|
| CHLAMYDIA (K843654) | Institute Virion , Ltd. | 1985-08-08 |
| CHLAMYDIA GROUP CF ANTIGEN (K844868) | Hillcrest Biologicals | 1985-03-05 |
| ANTIBODY TO CHLAMYDIA TRACHOMATIS (K811570) | Electro-Nucleonics Laboratories, Inc. | 1981-07-23 |
Recalls involving this device
No recalls on record reference this clearance.