FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
CRYO CHECK APC RESISTANT PLASMA
K Number: K971222
·
Decision Aug 19, 1997
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
98
Applicant Total
20
Review Days
139
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Basic Information
- Device Name
- CRYO CHECK APC RESISTANT PLASMA
- K Number
- K971222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Precision Biologicals, Inc.
- Date Received
- April 2, 1997
- Decision Date
- August 19, 1997
- Product Code
- GGN
- 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 |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | FDA class 2 | Hematology |
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Other Clearances by Precision Biologicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981173 | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) | Jan 13, 1999 | Substantially Equivalent |
| K982062 | CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 | Jan 13, 1999 | Substantially Equivalent |
| K981174 | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) | Jan 13, 1999 | Substantially Equivalent |
| K971219 | CRYO CHECK INR VALIDATION SET | Aug 29, 1997 | Substantially Equivalent |
| K971223 | CRYO CHECK FACTOR V DEFICIENT PLASMA | Jul 22, 1997 | Substantially Equivalent |
| K971227 | CRYO CHECK FACTOR X DEFICIENT PLASMA | Jul 18, 1997 | Substantially Equivalent |
| K971226 | CRYO CHECK FACTOR IX DEFICIENT PLASMA | Jul 18, 1997 | Substantially Equivalent |
| K971225 | CRYO CHECK FACTOR VIII DEFICIENT PLASMA | Jul 17, 1997 | Substantially Equivalent |
| K971224 | CRYO CHECK FACTOR VII DEFICIENT PLASMA | Jul 17, 1997 | Substantially Equivalent |
| K951823 | CRYO CHECK LOW FIBRINOGEN CONTROL | Jan 3, 1996 | Substantially Equivalent |