Zymed Laboratories Inc.
South San Francisco, CA
Zymed Laboratories Inc. appears in FDA device records in South San Francisco, CA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 2
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0015-05 | Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of cancer when used to test a patient. | Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings. | Terminated | ||
| Z-0014-05 | Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient. | Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain