FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCU-STAPH
K Number: K820347
·
Decision Mar 4, 1982
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
24
Review Days
24
Basic Information
- Device Name
- ACCU-STAPH
- K Number
- K820347
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- CARR-SCARBOROUGH MICROBIOLOGICALS, INC.
- Date Received
- February 8, 1982
- Decision Date
- March 4, 1982
- Product Code
- LHT
- 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 |
|---|---|---|---|
| LHT | Staphylococcus Aureus Somatic Antigens | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHT), ordered by most recent decision date.
STAPHYLASE TEST
FDA 510(k)
FDA Class 1
·Microbiology
SERO-STAT R II STAPHYLOCOCCUS TEST
FDA 510(k)
FDA Class 1
·Microbiology
ENDO-STAPH TEICHOIC ACID ANTIBODY KIT
FDA 510(k)
FDA Class 1
·Microbiology
STAPHYLOCOCCUS LATEX AGGLUTINATION KIT
FDA 510(k)
FDA Class 1
·Microbiology
DIAGNOSTIC KITS & KIT COMPONENTS
FDA 510(k)
FDA Class 1
·Microbiology
ADULT CHICKEN BLOOD IN ALSEVER'S, C., D.
FDA 510(k)
FDA Class 1
·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 |
| 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 |