CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT
FDA 510(k) clearance K915235 · decided 1992-01-28
Clearance details
- K-number
- K915235
- Device name
- CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT
- Applicant
- Incstar Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-11-22
- Decision date
- 1992-01-28
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- CDX
- Device class
- 2
- Regulation number
- 862.1700
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Incstar Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ELECSYS T4 ASSAY (K961490) | Boehringer Mannheim Corp. | 1996-06-13 |
| ACTIVE THYROXINE RIA (K954312) | Diagnostic Systems Laboratories, Inc. | 1995-10-07 |
| DELFIA NEONATAL THYROXINE KIT (K943416) | Wallac OY | 1995-03-10 |
| AXSYM(TM) TOTAL T4 (K934384) | Abbott Laboratories | 1994-06-21 |
| TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (K932980) | Sigma Diagnostics, Inc. | 1993-10-18 |
| STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (K933426) | Baxter Diagnostics, Inc. | 1993-08-26 |
| IQ TT4 ASSAY (K931295) | Becton Dickinson Advanced Diagnostics | 1993-07-20 |
| AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (K926563) | Bio-Chem Laboratory Systems, Inc. | 1993-03-18 |
| ABBOTT IMX T4 (K925110) | Abbott Laboratories | 1993-01-26 |
| ABBOTT TDX/TDXFLX TT4 (K925109) | Abbott Laboratories | 1993-01-04 |
| TECHNICON DAX SYSTEM THYROXINE (T4) METHOD (K922945) | Heraeus Kulzer, Inc. | 1992-10-14 |
| THYROXINE (T4) COATED TUBE RIA (K921935) | Monobind | 1992-07-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S003) | Incstar Corp. | 1993-07-23 |
| CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S002) | Incstar Corp. | 1991-03-28 |
| GAMMA DAB (125I) AFP RIA KIT (P790032/S001) | Incstar Corp. | 1986-08-22 |
| GAMMA DAB (125I) AFP RIA KIT (P790032) | Incstar Corp. | 1986-04-30 |