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510(k) K885244

SAF FECAL COLLECTION KIT by Precision Biologicals, Inc. — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1989
Date Received
December 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type

Other clearances by Precision Biologicals, Inc.

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  • K981174 — CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5M (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)
  • K971226 — CRYO CHECK FACTOR IX DEFICIENT PLASMA (July 18, 1997)
  • K971227 — CRYO CHECK FACTOR X DEFICIENT PLASMA (July 18, 1997)
  • K971225 — CRYO CHECK FACTOR VIII DEFICIENT PLASMA (July 17, 1997)
  • K971224 — CRYO CHECK FACTOR VII DEFICIENT PLASMA (July 17, 1997)

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