J & S IRON SATURATING REAGENT
FDA 510(k) clearance K811942 · decided 1981-09-08
Clearance details
- K-number
- K811942
- Device name
- J & S IRON SATURATING REAGENT
- Applicant
- Thyroid Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-07-07
- Decision date
- 1981-09-08
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- JQF
- Device class
- 1
- Regulation number
- 862.1415
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- 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 |
|---|---|---|
| SENTINEL UIBC LIQUID (K051111) | Sentinel Ch. Srl | 2005-11-17 |
| WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR (K984122) | Wako Chemicals USA, Inc. | 1999-01-20 |
| WAKO(TM) UIBC (K875176) | Wako Chemicals USA, Inc. | 1988-02-02 |
| TRANSFERMETER (K863066) | J. D. Assoc. | 1986-12-04 |
| TOTAL IRON BINDING CAPACITY TEST (K830032) | Sclavo, Inc. | 1983-01-28 |
| IRON & TICB (K810086) | Bio-Analytics Laboratories, Inc. | 1981-01-28 |
| ELVI TOTAL IRON BINDING CAPACITY (K792409) | Volu Sol Medical Industries | 1979-12-06 |
Recalls involving this device
No recalls on record reference this clearance.