FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT
FDA 510(k) clearance K884201 · decided 1988-12-14
Clearance details
- K-number
- K884201
- Device name
- FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT
- Applicant
- Cyberfluor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-10-06
- Decision date
- 1988-12-14
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- CEE
- Device class
- 2
- Regulation number
- 862.1685
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Ontario M5t 1x4, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMERLITE TBG ASSAY (K952284) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-26 |
| ACCESS THYROID UPTAKE ASSAY (K930010) | Bio-Rad Laboratories, Inc. | 1993-06-07 |
| IMMULITE(TM) T-UPTAKE (K910677) | Cirrus Diagnostics, Inc. | 1991-04-29 |
| MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT (K905777) | Immunotech Corp. | 1991-01-30 |
| DELFIA TBG KIT (K900240) | Pharmacia, Inc. | 1990-03-30 |
| ENZYMUN TEST(R) TBK (K896991) | Boehringer Mannheim Corp. | 1990-03-01 |
| AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT (K893469) | Amersham Corp. | 1989-08-15 |
| T-UPTAKE MICROASSAY (K885034) | Diamedix Corp. | 1989-02-02 |
| TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) (K874658) | Technicon Instruments Corp. | 1987-12-18 |
| ENZYMUN TEST TBG (K862109) | Boehringer Mannheim Corp. | 1986-06-30 |
| TIPSEP-TBG ASSAY (K861735) | Nuclear Diagnostics, Inc. | 1986-06-13 |
| TBG RIA (K842167) | Syncor Intl. Corp. | 1984-07-09 |
Recalls involving this device
No recalls on record reference this clearance.