FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST
K Number: K873312
·
Decision Feb 24, 1988
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
10
Applicant Total
5
Review Days
190
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST
- K Number
- K873312
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3020
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Cambridge Bioscience Corp.
- Date Received
- August 18, 1987
- Decision Date
- February 24, 1988
- Product Code
- GOD
- 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 |
|---|---|---|---|
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GOD), ordered by most recent decision date.
RPS ADENO DETECTOR PLUS
FDA 510(k)
FDA Class 1
·Microbiology
RPS ADENO DETECTOR
FDA 510(k)
FDA Class 1
·Microbiology
SAS ADENO TEST
FDA 510(k)
FDA Class 1
·Microbiology
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)
FDA 510(k)
FDA Class 1
·Microbiology
ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Cambridge Bioscience Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K890281 | HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES | Mar 15, 1989 | Substantially Equivalent |
| K881894 | ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) | Jul 8, 1988 | Substantially Equivalent |
| K873082 | ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST | Feb 24, 1988 | Substantially Equivalent |
| K852969 | ROTACLONE ROTAVIRUS DIAGNOSTIC KIT | Nov 5, 1985 | Substantially Equivalent |