FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOGROUPER 16C SYS AUTOMATED REAG
K Number: K834149
·
Decision Mar 9, 1984
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
30
Applicant Total
157
Review Days
99
Basic Information
- Device Name
- AUTOGROUPER 16C SYS AUTOMATED REAG
- K Number
- K834149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- TECHNICON INSTRUMENTS CORP.
- Date Received
- December 1, 1983
- Decision Date
- March 9, 1984
- Product Code
- GMQ
- 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 |
|---|---|---|---|
| GMQ | Antigens, Nontreponemal, All | FDA class 2 | Microbiology |
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