FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LAP DISCS
K Number: K905472
·
Decision Feb 27, 1991
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
243
Applicant Total
24
Review Days
83
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Basic Information
- Device Name
- LAP DISCS
- K Number
- K905472
- 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
- December 6, 1990
- Decision Date
- February 27, 1991
- Product Code
- JTO
- 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | FDA class 1 | Microbiology |
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Other Clearances by Carr-Scarborough Microbiologicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K905666 | M. CAT. BUTYRATE DISC | Feb 26, 1991 | Substantially Equivalent |
| K891476 | C. ALBICANS SCREEN | Apr 12, 1989 | 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 |