CRYO CHECK LUPUS PLASMA— 510(k) K952623
Substantially EquivalentPrecision Biologicals, Inc.
FDA 510(k) clearance K952623 for CRYO CHECK LUPUS PLASMA, Substantially Equivalent on 1995-11-06. Applicant: Precision Biologicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Precision Biologicals, Inc.
- Product code
- Code GGC
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dartmouth, Nova Scotia, CA
Recent devices under product code GGC
view allMore clearances from Precision Biologicals, Inc.
view all- K981173 — CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
- K981174 — CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
- K982062 — CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
- K971219 — CRYO CHECK INR VALIDATION SET
- K971222 — CRYO CHECK APC RESISTANT PLASMA
Data sourced from openFDA. This site is unofficial and independent of the FDA.