FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.
K Number: K894711
·
Decision Nov 14, 1989
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
62
Review Days
111
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Basic Information
- Device Name
- ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.
- K Number
- K894711
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Gen-Probe, Inc.
- Date Received
- July 26, 1989
- Decision Date
- November 14, 1989
- Product Code
- GTZ
- 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 |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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| K060652 | TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY | Aug 17, 2006 | Substantially Equivalent |
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| K043224 | GEN-PROBE APTIMA COMBO 2 ASSAY | Aug 9, 2005 | Substantially Equivalent |