FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BASIC CENTRIFUGE
K Number: K822422
·
Decision Sep 2, 1982
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
37
Applicant Total
21
Review Days
21
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Basic Information
- Device Name
- BASIC CENTRIFUGE
- K Number
- K822422
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biodynamics Corp.
- Date Received
- August 12, 1982
- Decision Date
- September 2, 1982
- Product Code
- JQC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Biodynamics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K051675 | BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER | Mar 16, 2006 | Substantially Equivalent |
| K884033 | BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER | Nov 17, 1988 | Substantially Equivalent |
| K881631 | BIODYNAMICS AUTOTRANSFUSION RESERVOIR | Sep 9, 1988 | Substantially Equivalent |
| K881968 | BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER | Jul 28, 1988 | Substantially Equivalent |
| K874361 | BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER | Mar 16, 1988 | Substantially Equivalent |
| 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 |