FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOSFOROMETER
K Number: K863072
·
Decision Sep 9, 1986
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
104
Applicant Total
34
Review Days
28
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
- FOSFOROMETER
- K Number
- K863072
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1580
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- J. D. Assoc.
- Date Received
- August 12, 1986
- Decision Date
- September 9, 1986
- Product Code
- CEO
- 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 |
|---|---|---|---|
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEO), ordered by most recent decision date.
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATAC PAK PHOSPHORUS REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PICCOLO PHOSPHORUS TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by J. D. Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K863103 | PEG 6,000 | Jan 13, 1987 | Substantially Equivalent |
| K863054 | AST S.C.E. (GOT) | Jan 13, 1987 | Substantially Equivalent |
| K863069 | MAGNESIOMETER | Dec 31, 1986 | Substantially Equivalent |
| K863079 | CREATINKINETIC | Dec 12, 1986 | Substantially Equivalent |
| K863112 | PROTEINMETER | Dec 10, 1986 | Substantially Equivalent |
| K863068 | LDH S.C.E. | Dec 10, 1986 | Substantially Equivalent |
| K863053 | ALT S.C.E. (GPT) | Dec 10, 1986 | Substantially Equivalent |
| K863066 | TRANSFERMETER | Dec 4, 1986 | Substantially Equivalent |
| K863109 | FERROFAST | Nov 24, 1986 | Substantially Equivalent |
| K863102 | GLUCOMETER-E | Nov 24, 1986 | Substantially Equivalent |