FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COULTER ACCU-ZYME II ENZYMATIC REAGENT
K Number: K791640
·
Decision Sep 24, 1979
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
101
Review Days
34
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
- COULTER ACCU-ZYME II ENZYMATIC REAGENT
- K Number
- K791640
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Coulter Electronics, Inc.
- Date Received
- August 21, 1979
- Decision Date
- September 24, 1979
- 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 Coulter Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923951 | CD8 CYTOSPHERES KIT | Apr 25, 1994 | Substantially Equivalent |
| K930119 | COULTER RETIC-C CELL CONTROL | Apr 5, 1993 | Substantially Equivalent |
| K921279 | CD4 CYTOSPHERES KIT | Dec 29, 1992 | Substantially Equivalent |
| K923530 | COULTER MULTI-Q-PREP | Oct 14, 1992 | Substantially Equivalent |
| K922181 | COULTER MH009 | Aug 17, 1992 | Substantially Equivalent |
| K922704 | COULTER MAXM W/ AUTOLOADER | Jul 27, 1992 | Substantially Equivalent |
| K921567 | COULTER MH017 | Jul 6, 1992 | Substantially Equivalent |
| K912133 | PX COULTER(R) CELL CONTROL | Jul 17, 1991 | Substantially Equivalent |
| K911385 | COULTER(R) MH010 | Jun 17, 1991 | Substantially Equivalent |
| K905771 | COULTER DART AST (GOT) REAGENT | Feb 26, 1991 | Substantially Equivalent |