The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Pregna-zyme.
| Device ID | K850992 |
| 510k Number | K850992 |
| Device Name: | PREGNA-ZYME |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Contact | Stephen Kolakowsky |
| Correspondent | Stephen Kolakowsky ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-11 |
| Decision Date | 1985-05-01 |