FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY
K Number: K862428
·
Decision Aug 19, 1986
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
149
Review Days
54
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY
- K Number
- K862428
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- American Dade
- Date Received
- June 26, 1986
- Decision Date
- August 19, 1986
- Product Code
- JLW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JLW), ordered by most recent decision date.
Atellica® IM TSH3-Ultra II (TSH3ULII)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by American Dade
| K Number | Device Name | ||
|---|---|---|---|
| K873051 | STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY | Oct 20, 1987 | Substantially Equivalent |
| K873171 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Sep 29, 1987 | Substantially Equivalent |
| K873052 | STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY | Sep 14, 1987 | Substantially Equivalent |
| K872789 | PARAMAX URINE/CSF CALIBRATOR | Sep 2, 1987 | Substantially Equivalent |
| K872195 | DATA-FI DIMERTEST LATEX ASSAY | Aug 6, 1987 | Substantially Equivalent |
| K872196 | AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III | Jul 31, 1987 | Substantially Equivalent |
| K871972 | STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY | Jul 21, 1987 | Substantially Equivalent |
| K871977 | DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR | Jul 9, 1987 | Substantially Equivalent |
| K872050 | PARAMAX CHOLESTEROL REAGENT | Jul 7, 1987 | Substantially Equivalent |
| K872360 | DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET | Jul 6, 1987 | Substantially Equivalent |