IMMUNOZYME E. HISTOLYTICA ANTIGENS
FDA 510(k) clearance K780114 · decided 1978-04-19
Clearance details
- K-number
- K780114
- Device name
- IMMUNOZYME E. HISTOLYTICA ANTIGENS
- Applicant
- Millipore Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-01-23
- Decision date
- 1978-04-19
- Days to decision
- 86 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 |
|---|---|---|
| THERAPEUTIC APHERESIS SYSTEM (P850092) | Millipore Corp. | 1986-11-18 |