FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
C. ALBICANS SCREEN
K Number: K891476
·
Decision Apr 12, 1989
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
5
Applicant Total
24
Review Days
27
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Basic Information
- Device Name
- C. ALBICANS SCREEN
- K Number
- K891476
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Carr-Scarborough Microbiologicals, Inc.
- Date Received
- March 16, 1989
- Decision Date
- April 12, 1989
- Product Code
- JXC
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JXC | Kit, Screening, Yeast | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JXC), ordered by most recent decision date.
CHROMAGAR CANDIDA
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ALBICANS SURE
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SOC SLIDE CULTURE SYSTEM
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QUANTUM II YEAST IDENT. SYSTEM
FDA 510(k)
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·Microbiology
Other Clearances by Carr-Scarborough Microbiologicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944554 | BRAIN HEART INFUSION AGAR | Oct 4, 1994 | Substantially Equivalent |
| K941985 | MUELLER HINTON AGAR W/OXACILLIN | Aug 24, 1994 | Substantially Equivalent |
| K905472 | LAP DISCS | Feb 27, 1991 | Substantially Equivalent |
| K905666 | M. CAT. BUTYRATE DISC | Feb 26, 1991 | Substantially Equivalent |
| K882630 | PRO DISCS | Feb 16, 1989 | Substantially Equivalent |
| K882636 | ALN DISCS | Feb 16, 1989 | Substantially Equivalent |
| K863216 | NEIS NZY | Sep 15, 1986 | Substantially Equivalent |
| K860301 | RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE | Feb 6, 1986 | Substantially Equivalent |
| K860302 | PYR DISCS | Feb 5, 1986 | Substantially Equivalent |
| K822930 | CSM CHROMOGENIC B-LACTAMASE DISC | Nov 1, 1982 | Substantially Equivalent |