FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BCA 1000
K Number: K810105
·
Decision Feb 2, 1981
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
21
Review Days
17
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Basic Information
- Device Name
- BCA 1000
- K Number
- K810105
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biodynamics Corp.
- Date Received
- January 16, 1981
- Decision Date
- February 2, 1981
- Product Code
- JJQ
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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| K873807 | AUTOTRANSFUSION APPARATUS | Mar 9, 1988 | Substantially Equivalent |
| K874034 | ADR-22 AUTOMATIC DIALYZER REPROCESSOR | Oct 23, 1987 | Substantially Equivalent |
| K870052 | INFUMIX MIXING CONTAINER | Feb 27, 1987 | Substantially Equivalent |
| K822716 | UNIVERSAL CENTRIFUGE | Sep 30, 1982 | Substantially Equivalent |
| K822715 | PLATELET CENTRIFUGE | Sep 30, 1982 | Substantially Equivalent |