FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCEAN SCIENTIFIC VDRL TEST
K Number: K864731
·
Decision Mar 10, 1987
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
31
Applicant Total
6
Review Days
96
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Basic Information
- Device Name
- OCEAN SCIENTIFIC VDRL TEST
- K Number
- K864731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Ocean Scientific, Inc.
- Date Received
- December 4, 1986
- Decision Date
- March 10, 1987
- 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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Other Clearances by Ocean Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893810 | IMMUNO-WASH AUTOMATED TUBE WASHER | Aug 3, 1989 | Substantially Equivalent |
| K873638 | MICRO-CHEM ANALYZER | Sep 29, 1987 | Substantially Equivalent |
| K863976 | OCEAN SCIENTIFIC VACUTEST | Oct 24, 1986 | Substantially Equivalent |
| K860987 | MINI-CHEM ANALYZER | May 5, 1986 | Substantially Equivalent |
| K840340 | CHEM-STAT ANALYZER | Mar 23, 1984 | Substantially Equivalent |