The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Cbc Pap Test Kit.
| Device ID | K802153 |
| 510k Number | K802153 |
| Device Name: | CBC PAP TEST KIT |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| Applicant | CALBIOCHEM-BEHRING CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JFH |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-08 |
| Decision Date | 1980-11-12 |