The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Test Aptt-sp.
| Device ID | K973306 |
| 510k Number | K973306 |
| Device Name: | IL TEST APTT-SP |
| Classification | Activated Partial Thromboplastin |
| Applicant | INSTRUMENTATION LABORATORY CO. 526 RT. 303 Orangeburg, NY 10962 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 526 RT. 303 Orangeburg, NY 10962 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-03 |
| Decision Date | 1997-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950078937 | K973306 | 000 |
| 08426950023487 | K973306 | 000 |