FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSE(HEXOKINASE) REAGENT SET
K Number: K844998
·
Decision Jan 18, 1985
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
144
Applicant Total
15
Review Days
23
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
- GLUCOSE(HEXOKINASE) REAGENT SET
- K Number
- K844998
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sterling Biochemical, Inc.
- Date Received
- December 26, 1984
- Decision Date
- January 18, 1985
- Product Code
- CFR
- 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 |
|---|---|---|---|
| CFR | Hexokinase, Glucose | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFR), ordered by most recent decision date.
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Glucose2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Sterling Biochemical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K844251 | ALT/GPT REAGENT SET | Jan 8, 1985 | Substantially Equivalent |
| K843332 | ALKALINE PHOSPHATASE REAGENT SET | Sep 14, 1984 | Substantially Equivalent |
| K842521 | AST/GOT REAGENT SET UV RATE | Aug 12, 1984 | Substantially Equivalent |
| K840064 | UREA NITROGEN REAGENT SET | Jun 14, 1984 | Substantially Equivalent |
| K834084 | HYDROXYBUTYRATE DEHYDROGENASE REAGENT | Feb 4, 1984 | Substantially Equivalent |
| K834045 | URIC ACID REAGENT SET | Jan 30, 1984 | Substantially Equivalent |
| K833864 | AMYLASE REAGENT SET-MODIFIED CARAWAY | Jan 13, 1984 | Substantially Equivalent |
| K833062 | SERUM CHOLINESTERASE REAGENT SET | Nov 25, 1983 | Substantially Equivalent |
| K831874 | LIPASE REAGENT SET | Aug 12, 1983 | Substantially Equivalent |
| K831415 | LACTIC DEHYDROGENASE REAGENT SET | Jun 16, 1983 | Substantially Equivalent |