FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REFRACTROL-SP
K Number: K926095
·
Decision Jan 26, 1993
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
40
Review Days
55
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Basic Information
- Device Name
- REFRACTROL-SP
- K Number
- K926095
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Specialties, Inc.
- Date Received
- December 2, 1992
- Decision Date
- January 26, 1993
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| K896566 | MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE | Feb 9, 1990 | Substantially Equivalent |
| K883703 | MSI-CAL 7 | Nov 22, 1988 | Substantially Equivalent |
| K883851 | MSI-CAL 8 | Nov 22, 1988 | Substantially Equivalent |
| K883850 | MSI-CAL 16 | Nov 22, 1988 | Substantially Equivalent |
| K880608 | MSI-PC | Mar 21, 1988 | Substantially Equivalent |
| K880270 | MSI-DIFF PLUS | Mar 1, 1988 | Substantially Equivalent |
| K872140 | (MSI) PATH-SAVER | Jun 15, 1987 | Substantially Equivalent |