FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REAGENTS
K Number: K761086
·
Decision Jan 12, 1977
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
31
Applicant Total
14
Review Days
58
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Basic Information
- Device Name
- REAGENTS
- K Number
- K761086
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Simmler & Son, Inc.
- Date Received
- November 15, 1976
- Decision Date
- January 12, 1977
- Product Code
- JJC
- 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 |
|---|---|---|---|
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Simmler & Son, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K780817 | GLOBIN-TERGE | Jul 27, 1978 | Substantially Equivalent |
| K771903 | LIPASE | Dec 6, 1977 | Substantially Equivalent |
| K771906 | PHOSPHATE | Dec 6, 1977 | Substantially Equivalent |
| K771905 | GLYCEROL SUBSTRATE | Dec 6, 1977 | Substantially Equivalent |
| K771904 | GLYCEROL KINASE | Dec 6, 1977 | Substantially Equivalent |
| K760476 | REAGENT, LACTATE DEHYDROGENASE | Nov 1, 1976 | Substantially Equivalent |
| K760473 | REAGENT, ALBUMIN DETERMINATION | Oct 29, 1976 | Substantially Equivalent |
| K760478 | REAGENT, BUN (UREA NITROGEN) DETERM. | Oct 29, 1976 | Substantially Equivalent |
| K760474 | REAGENT, ALKALINE PHOSPHATASE DETERM. | Oct 29, 1976 | Substantially Equivalent |
| K760480 | REAGENT, TOTAL PROTEIN DETERMINATION | Oct 29, 1976 | Substantially Equivalent |