PHADEZYM B2 MICRO TEST 100
FDA 510(k) clearance K830280 · decided 1983-03-25
Clearance details
- K-number
- K830280
- Device name
- PHADEZYM B2 MICRO TEST 100
- Applicant
- Pharmacia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-26
- Decision date
- 1983-03-25
- Days to decision
- 58 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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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 |