The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Single-step Pregnancy, Hcg Test.
| Device ID | K922290 |
| 510k Number | K922290 |
| Device Name: | SINGLE-STEP PREGNANCY, HCG TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | AMERICAN MEDICAL PRODUCTS, INC. 510 HERON DRIVE, BLDG. 306 P.O. BOX 521 Bridgeport, NJ 08014 |
| Contact | Martin R Gould |
| Correspondent | Martin R Gould AMERICAN MEDICAL PRODUCTS, INC. 510 HERON DRIVE, BLDG. 306 P.O. BOX 521 Bridgeport, NJ 08014 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-15 |
| Decision Date | 1992-07-09 |