FDA 510(k)
Substantially Equivalent
🇺🇸 United States
GLOBIN-TERGE
K Number: K780817
·
Decision Jul 27, 1978
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
14
Review Days
70
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Basic Information
- Device Name
- GLOBIN-TERGE
- K Number
- K780817
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Simmler & Son, Inc.
- Date Received
- May 18, 1978
- Decision Date
- July 27, 1978
- Advisory Committee
- Unknown
- Review Advisory Committee
- HE
- Third Party
- N
Other Clearances by Simmler & Son, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K761086 | REAGENTS | Jan 12, 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 |