PHADEBACT CSF TEST
FDA 510(k) clearance K844999 · decided 1985-10-17
Clearance details
- K-number
- K844999
- Device name
- PHADEBACT CSF TEST
- Applicant
- Pharmacia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-26
- Decision date
- 1985-10-17
- Days to decision
- 295 days
- Clearance type
- Traditional
- Product code
- GTJ
- Device class
- 2
- Regulation number
- 866.3390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Piscataway, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MODELS 011 & 011B IRIDOCAPSULAR IOLS (P810042) | Pharmacia, Inc. | 1982-12-15 |