The following data is part of a premarket notification filed by Acon Laboratories Co. with the FDA for Acon Hcg One Step Urine/serum Pregnancy Test.
| Device ID | K980736 |
| 510k Number | K980736 |
| Device Name: | ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | ACON LABORATORIES CO. 115 RESEARCH DR. Bethlehem, PA 18015 |
| Contact | Patricia E Bonness |
| Correspondent | Patricia E Bonness ACON LABORATORIES CO. 115 RESEARCH DR. Bethlehem, PA 18015 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-25 |
| Decision Date | 1998-04-16 |
| Summary: | summary |