FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMPROVED GRAM STAIN REAGENTS
K Number: K791711
·
Decision Oct 17, 1979
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
5
Applicant Total
24
Review Days
50
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Basic Information
- Device Name
- IMPROVED GRAM STAIN REAGENTS
- K Number
- K791711
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Carr-Scarborough Microbiologicals, Inc.
- Date Received
- August 28, 1979
- Decision Date
- October 17, 1979
- Product Code
- HYI
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| HYI | Iodine, Grams | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HYI), ordered by most recent decision date.
GRAM IODINE
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GRAM IODINE
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PARA-PAK
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GRAM STAIN KIT
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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 |
| 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 |