FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFECRIT PLASTIC MICROHEMATOCRIT TUBES
K Number: K883185
·
Decision Aug 18, 1988
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
1
Applicant Total
7
Review Days
21
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SAFECRIT PLASTIC MICROHEMATOCRIT TUBES
- K Number
- K883185
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Norfolk Scientific, Inc.
- Date Received
- July 28, 1988
- Decision Date
- August 18, 1988
- Product Code
- GHY
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| GHY | Hematocrit, Tube, Rack, Sealer, Holder | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GHY), ordered by most recent decision date.
View allOther 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 |
| K881254 | STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 | Apr 5, 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 |