510(k) K012208
- Device
- ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K012208
- Product code
- DDC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-09-07
- Date received
- 2001-07-16
- Regulation
- 866.5870
- Classification name
- Thyroglobulin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DENISE THOMPSON
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 9612316
- 2026994
- 3012348571
- 3003750284
- 3022178699
- 8031673
- 2020726
- 2245285
- 2242436
- 2029372
- 3002800697
Source Documents#
Other 510(k) Records For Product Code DDC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023592 | SERAQUEST ANTI-THYROGLOBULIN | Quest Intl., Inc. | 2003-01-06 |
| K000363 | MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 2000-02-18 |
| K991610 | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. | Zeus Scientific, Inc. | 1999-06-25 |
| K991179 | ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-06-17 |
| K971835 | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA | Monobind | 1997-07-03 |
| K953066 | SERODIA ATG | Fujirebio America, Inc. | 1995-08-14 |
| K943625 | AUTOSTAT II ANTI-THYROGLOBULIN | Cogent Diagnotics , Ltd. | 1994-12-22 |
| K936010 | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY | Biomerica, Inc. | 1994-07-18 |
| K930486 | QUANTA LITE(TM) THYROID T ELISA | Inova Diagnostics, Inc. | 1993-03-15 |
| K865020 | SERA-TEK THYROGLOBULIN ANTIBODY TEST | Miles Laboratories, Inc. | 1987-02-02 |
| K780873 | THYMUNE-M | Burroughs Wellcome Co. | 1978-06-14 |
| K780874 | THYMUNE-T | Burroughs Wellcome Co. | 1978-06-14 |
Legacy Summary#
summary
FDA Review#
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