Tsh Control
510(k) K915325
Tsh Control is a medical device (FDA Class I; FDA product code JJX, Single (Specified) Analyte Controls (Assayed And Unassayed)) made by Polymedco, Inc., cleared under FDA 510(k) K915325 on 2 Mar 1992, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK915325 | Date2 Mar 1992 | StatusActive |
Official records
- FDA 510(k) database K915325
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JJX
- Device class
- Class I
- Regulation
- 21 CFR Part 862.1660
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)).
- DUPONT ACA CKMB VERIFIERS by E.I. Dupont DE Nemours & Co., Inc.
- AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET by Tosoh Medics, Inc.
- ARCHITECT 6K89-20 06K8920 by Abbott Laboratories
- REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL by Streck Laboratories, Inc.
- IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) by Siemens Healthcare Diagnostics
- LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION by Bionostics, Inc.
- LEVEL II CONTROL SERUM by IRVINE SCIENTIFIC, LLC
- ADVIA Centaur aTPOII MCM 11203693 by Siemens Healthcare Diagnostics Inc.
- AUDIT MICROCV T-UPTAKE LINEARITY by Aalto Scientific, Ltd.
- ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO by Beckman Instruments, Inc.