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510(k) K952622

CRYO CHECK NORMAL HUMAN REFERENCE PLASMA by Precision Biologicals, Inc. — Product Code GGN

K952622 is an FDA 510(k) premarket notification submitted by Precision Biologicals, Inc. for the device "CRYO CHECK NORMAL HUMAN REFERENCE PLASMA". The FDA issued a decision of Substantially Equivalent on October 30, 1995. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Precision Biologicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1995
Date Received
June 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Precision Biologicals, Inc.

  • K981174 — CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5M (January 13, 1999)
  • K982062 — CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 (January 13, 1999)
  • K981173 — CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5M (January 13, 1999)
  • K971219 — CRYO CHECK INR VALIDATION SET (August 29, 1997)
  • K971222 — CRYO CHECK APC RESISTANT PLASMA (August 19, 1997)
  • K971223 — CRYO CHECK FACTOR V DEFICIENT PLASMA (July 22, 1997)
  • K971227 — CRYO CHECK FACTOR X DEFICIENT PLASMA (July 18, 1997)
  • K971226 — CRYO CHECK FACTOR IX DEFICIENT PLASMA (July 18, 1997)
  • K971224 — CRYO CHECK FACTOR VII DEFICIENT PLASMA (July 17, 1997)
  • K971225 — CRYO CHECK FACTOR VIII DEFICIENT PLASMA (July 17, 1997)

Other clearances for product code GGN

  • K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (June 21, 2017)
  • K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit (March 16, 2017)
  • K161316 — George King Coumadin Plasma (February 23, 2017)
  • K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (January 5, 2017)
  • K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (June 3, 2016)
  • K150144 — VisuCon-F Low Fibrinogen Control Plasma (March 6, 2016)
  • K142132 — POOL NORM (December 12, 2014)
  • K133582 — HEMOSIL D-DIMER HS 500 CONTROL (August 15, 2014)
  • K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DI (July 3, 2013)
  • K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (May 31, 2013)

FDA data resources