The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Phadebact Csf Test 20.
| Device ID | K822810 |
| 510k Number | K822810 |
| Device Name: | PHADEBACT CSF TEST 20 |
| Classification | Antisera, All Groups, N. Meningitidis |
| Applicant | PHARMACIA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GTJ |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-20 |
| Decision Date | 1982-12-30 |