FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
K Number: K950803
·
Decision Sep 21, 1995
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
44
Review Days
212
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Basic Information
- Device Name
- ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
- K Number
- K950803
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Isolab, Inc.
- Date Received
- February 21, 1995
- Decision Date
- September 21, 1995
- Product Code
- JJT
- 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Isolab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951014 | ISOLAB'S T4 TEST KIT | Oct 18, 1996 | Substantially Equivalent |
| K950481 | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT | Feb 1, 1996 | Substantially Equivalent |
| K943547 | PHENYLALANINE TEST KIT | Jan 26, 1996 | Substantially Equivalent |
| K950415 | FLUOROSCAN NEONATAL | Sep 5, 1995 | Substantially Equivalent |
| K942276 | QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY | Jan 20, 1995 | Substantially Equivalent |
| K942222 | QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS | Jan 20, 1995 | Substantially Equivalent |
| K944185 | ISOSCAN | Nov 17, 1994 | Substantially Equivalent |
| K934013 | RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT | Apr 26, 1994 | Substantially Equivalent |
| K923153 | HEMOCARD, HEMOGLOBIN C ASSAY | Jan 27, 1994 | Substantially Equivalent |
| K931234 | HEMOCARD CONTROL HB-AA, AE, FAA, FAE | May 11, 1993 | Substantially Equivalent |