The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Brand Name *1-step Pregnancy.
| Device ID | K973352 |
| 510k Number | K973352 |
| Device Name: | BRAND NAME *1-STEP PREGNANCY |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 -0181 |
| Contact | Theresa Sines |
| Correspondent | Theresa Sines ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 -0181 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-05 |
| Decision Date | 1997-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00022600901266 | K973352 | 000 |
| 00022600649168 | K973352 | 000 |