FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01
K Number: K881254
·
Decision Apr 5, 1988
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
37
Applicant Total
7
Review Days
13
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Basic Information
- Device Name
- STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01
- K Number
- K881254
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Norfolk Scientific, Inc.
- Date Received
- March 23, 1988
- Decision Date
- April 5, 1988
- Product Code
- JQC
- 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 |
|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Norfolk Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902028 | STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER | Jun 20, 1990 | Substantially Equivalent |
| K890669 | STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE | Mar 8, 1989 | Substantially Equivalent |
| K883185 | SAFECRIT PLASTIC MICROHEMATOCRIT TUBES | Aug 18, 1988 | Substantially Equivalent |
| K870511 | CHART-TYPE MICRO HEMATOCRIT TUBE READER | Mar 16, 1987 | Substantially Equivalent |
| K864974 | GENERAL PURPOSE CENTRIFUGE | Jan 9, 1987 | Substantially Equivalent |
| K860172 | QWIKSPIN (TM) | Feb 11, 1986 | Substantially Equivalent |