The following data is part of a premarket notification filed by Kronus Market Development Associates, Inc. with the FDA for Tsh Receptor Antibody (trab) Coated Tube (ct) Assay Kit.
| Device ID | K032134 |
| 510k Number | K032134 |
| Device Name: | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 12554 WEST BRIDGER ST. SUITE 108 Boise, ID 83713 |
| Contact | Heather Viele |
| Correspondent | Heather Viele KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 12554 WEST BRIDGER ST. SUITE 108 Boise, ID 83713 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-11 |
| Decision Date | 2003-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B126KR71200 | K032134 | 000 |
| B126KR70600 | K032134 | 000 |
| 00840239033697 | K032134 | 000 |
| 04048474033694 | K032134 | 000 |