International Chemical Inc.
Amherst, NY
International Chemical Inc. appears in FDA device records in Amherst, NY. 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-0453-05 | OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper. Label states: ''Easy to Use, Easy Reading, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by: ICC, Amherst, NY 14228 | Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible. | Terminated | ||
| Z-0452-05 | OTC Pregnancy Test labeled ''CHOICE Pregnancy Test Kit'' (PA-410A), midstream, no cups or droppers. Label reads: ''One Step, Easy to Use, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by ICC, Amherst, NY 14228. | Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain