PREGNASLIDE
Agglutination Method, Human Chorionic Gonadotropin
ARMKEL, LLC.
The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Pregnaslide.
Pre-market Notification Details
| Device ID | K863198 |
| 510k Number | K863198 |
| Device Name: | PREGNASLIDE |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| 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 | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-19 |
| Decision Date | 1986-09-29 |
Trademark Results [PREGNASLIDE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PREGNASLIDE 73648123 1479218 Dead/Cancelled |
CARTER-WALLACE, INC. 1987-03-06 |
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