FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT
K Number: K897169
·
Decision Feb 23, 1990
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
12
Review Days
57
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
- QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT
- K Number
- K897169
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Photec Diagnostics, Inc.
- Date Received
- December 28, 1989
- Decision Date
- February 23, 1990
- Product Code
- CDT
- 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 |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDT), ordered by most recent decision date.
Triglycerides
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VANTERA CLINICAL ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OLYMPUS TRIGLYCERIDE TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Photec Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896329 | D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. | Dec 12, 1989 | Substantially Equivalent |
| K894057 | QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT | Aug 31, 1989 | Substantially Equivalent |
| K892224 | D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN | Jun 16, 1989 | Substantially Equivalent |
| K890267 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA | Apr 26, 1989 | Substantially Equivalent |
| K890027 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD | Apr 26, 1989 | Substantially Equivalent |
| K882307 | D-CHEM | Aug 2, 1988 | Substantially Equivalent |
| K880291 | THEOPHYLLINE TEST KIT REF. #A874799 | Mar 24, 1988 | Substantially Equivalent |
| K854875 | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | Jan 24, 1986 | Substantially Equivalent |
| K853048 | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 | Aug 28, 1985 | Substantially Equivalent |
| K853174 | APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN | Aug 22, 1985 | Substantially Equivalent |