The following data is part of a premarket notification filed by Ampcor, Inc. with the FDA for Single And Dual Band Dipstick Hcg Test.
| Device ID | K893873 |
| 510k Number | K893873 |
| Device Name: | SINGLE AND DUAL BAND DIPSTICK HCG TEST |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport, NJ 08014 |
| Contact | Raymond Gould |
| Correspondent | Raymond Gould AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport, NJ 08014 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-26 |
| Decision Date | 1989-08-21 |