The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for One -step Urine/serum Combo Pregnancy Card Test.
| Device ID | K964461 |
| 510k Number | K964461 |
| Device Name: | ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Contact | Andrew Reams |
| Correspondent | Andrew Reams TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-07 |
| Decision Date | 1997-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486002409 | K964461 | 000 |
| 10673486002454 | K964461 | 000 |