FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAPID CHEM ANALYZER II
K Number: K830095
·
Decision Jan 28, 1983
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
23
Review Days
17
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
- RAPID CHEM ANALYZER II
- K Number
- K830095
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Macomb Chemical Co.
- Date Received
- January 11, 1983
- Decision Date
- January 28, 1983
- Product Code
- JJF
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJF), ordered by most recent decision date.
ETI-MAX 3000
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIGHTCYCLER INSTRUMENT VERSION 1.2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ROCHE COBAS TAQMAN ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CARESIDE ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Macomb Chemical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K823720 | SPECTROPHOTOMETER | Jan 7, 1983 | Substantially Equivalent |
| K810958 | GLYCOHEMOGLOBIN | Sep 16, 1981 | Substantially Equivalent |
| K801086 | P-NITROPHENYL PHOSPHATE | May 28, 1980 | Substantially Equivalent |
| K800719 | ENZYMATIC UREA NITROGEN REAGENT SET REVI | May 8, 1980 | Substantially Equivalent |
| K800720 | MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO | Apr 21, 1980 | Substantially Equivalent |
| K792532 | GLUCOSE (HEXOKINASE) REAGENT SET | Jan 11, 1980 | Substantially Equivalent |
| K792533 | CREATINE PHOSPHOKINASE (CPK) REAGENT SET | Jan 11, 1980 | Substantially Equivalent |
| K791669 | GLUCOSE OXIDASE REAGENT SET | Sep 24, 1979 | Substantially Equivalent |
| K791511 | ENZYMATIC REAGENT SET, 4X250 ML. | Sep 4, 1979 | Substantially Equivalent |
| K791119 | MACOMB NORMAL CONTROL SERUM | Jul 30, 1979 | Substantially Equivalent |