FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUOROSCAN NEONATAL
K Number: K950415
·
Decision Sep 5, 1995
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
44
Review Days
217
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Basic Information
- Device Name
- FLUOROSCAN NEONATAL
- K Number
- K950415
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2560
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Isolab, Inc.
- Date Received
- January 31, 1995
- Decision Date
- September 5, 1995
- Product Code
- KHO
- 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 |
|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | 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 |
| K950803 | ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE | Sep 21, 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 |