FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIGLYCERIDES TEST (500NM)
K Number: K800551
·
Decision Mar 25, 1980
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
21
Applicant Total
63
Review Days
15
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
- TRIGLYCERIDES TEST (500NM)
- K Number
- K800551
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Reagents Applications, Inc.
- Date Received
- March 10, 1980
- Decision Date
- March 25, 1980
- Product Code
- JGY
- 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 |
|---|---|---|---|
| JGY | Colorimetric Method, Triglycerides | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JGY), ordered by most recent decision date.
PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PICCOLO TRIGLYCERIDES TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIOSCANNER TRIGLYCERIDES TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIOSCANNER TRIGLYCERIDES TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TRIGLYCERIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TRIGLYCERIDES REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Reagents Applications, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982056 | RAICHEM CO2 REAGENT | Jun 24, 1998 | Substantially Equivalent |
| K972853 | CHOLESTEROL RAPID LIQUID REAGENT | Sep 24, 1997 | Substantially Equivalent |
| K922904 | RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II | Jul 30, 1992 | Substantially Equivalent |
| K915191 | RAI-TROL ELEVATED LIPIDS CONTROL | Dec 18, 1991 | Substantially Equivalent |
| K913398 | RAICHEM(TM) CREATINE KINASE-MB REAGENT | Sep 25, 1991 | Substantially Equivalent |
| K911900 | RAICHEM SPIA C3 REAGENT | May 9, 1991 | Substantially Equivalent |
| K911899 | RAICHEM SPIA C4 REAGENT | May 9, 1991 | Substantially Equivalent |
| K911898 | RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT | May 8, 1991 | Substantially Equivalent |
| K905084 | RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV | Dec 20, 1990 | Substantially Equivalent |
| K905085 | RAICHEM GGT REAGENT | Dec 20, 1990 | Substantially Equivalent |