The following data is part of a premarket notification filed by Tcpi, Inc. with the FDA for One Step Pregnancy Hcg Serun Diluent Reagent.
| Device ID | K955353 |
| 510k Number | K955353 |
| Device Name: | ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | TCPI, INC. 3341 S.W. 15TH ST. Pompano Beach, FL 33069 |
| Contact | Cleve W Laird |
| Correspondent | Cleve W Laird TCPI, INC. 3341 S.W. 15TH ST. Pompano Beach, FL 33069 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-21 |
| Decision Date | 1996-03-19 |
| Summary: | summary |