The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign, Biosign Pcp.
| Device ID | K961266 |
| 510k Number | K961266 |
| Device Name: | ACCUSIGN, BIOSIGN PCP |
| Classification | Enzyme Immunoassay, Phencyclidine |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. ROUTE 1 P.O. BOX 7139 Monmouth Junction, NJ 08852 -1905 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. 4242 U.S. ROUTE 1 P.O. BOX 7139 Monmouth Junction, NJ 08852 -1905 |
| Product Code | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-02 |
| Decision Date | 1996-05-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10743816000136 | K961266 | 000 |
| 10743816000129 | K961266 | 000 |