ONE STEP LH TEST
Radioimmunoassay, Luteinizing Hormone
TCPI, INC.
The following data is part of a premarket notification filed by Tcpi, Inc. with the FDA for One Step Lh Test.
Pre-market Notification Details
| Device ID | K935134 |
| 510k Number | K935134 |
| Device Name: | ONE STEP LH TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | TCPI, INC. P.O. BOX 8726 Ft. Lauderdale, FL 33310 -8726 |
| Contact | Cleve W Laird, Ph.d. |
| Correspondent | Cleve W Laird, Ph.d. TCPI, INC. P.O. BOX 8726 Ft. Lauderdale, FL 33310 -8726 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-28 |
| Decision Date | 1994-01-11 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10855606007086 | K935134 | 000 |
Trademark Results [ONE STEP LH TEST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ONE STEP LH TEST 74455877 not registered Dead/Abandoned |
Technical Chemicals and Products, Inc. 1993-11-09 |
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