FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCEAN SCIENTIFIC VACUTEST
K Number: K863976
·
Decision Oct 24, 1986
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
6
Review Days
10
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Basic Information
- Device Name
- OCEAN SCIENTIFIC VACUTEST
- K Number
- K863976
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ocean Scientific, Inc.
- Date Received
- October 14, 1986
- Decision Date
- October 24, 1986
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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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 |
| K864731 | OCEAN SCIENTIFIC VDRL TEST | Mar 10, 1987 | Substantially Equivalent |
| K860987 | MINI-CHEM ANALYZER | May 5, 1986 | Substantially Equivalent |
| K840340 | CHEM-STAT ANALYZER | Mar 23, 1984 | Substantially Equivalent |