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510(k) K761177

SODIUM CITRATE by Bio/Data Corp. — Product Code GJE

K761177 is an FDA 510(k) premarket notification submitted by Bio/Data Corp. for the device "SODIUM CITRATE". The FDA issued a decision of Substantially Equivalent on January 10, 1977. The device falls under product code GJE (Tray, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Bio/Data Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1977
Date Received
December 1, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Bio/Data Corp.

  • K001891 — MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C (July 12, 2000)
  • K943153 — MICROSAMPLE COAGULATION ANALYZER (March 24, 1995)
  • K893650 — PLATELET AGGREGATION PROFILER MODEL PAP-4C (June 23, 1989)
  • K881150 — KINETIC FIBRINOGEN ASSAY (March 28, 1988)
  • K873382 — PLATELET EXTRACT REAGENT (November 20, 1987)
  • K860751 — VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA (March 18, 1986)
  • K860342 — MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP (March 4, 1986)
  • K854546 — MICROSAMPLE COAGULATION ANALYSER MODEL 110P (January 7, 1986)
  • K853897 — CITREX H (October 10, 1985)
  • K853246 — CALCIUM CHLORIDE (August 13, 1985)

Other clearances for product code GJE

  • K962596 — CUSTOMED BLOOD EXTRACTION KIT (September 27, 1996)
  • K925468 — JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT (April 11, 1994)
  • K780303 — AUTO ISO-FILTER COLLECTION TUBE CAP (March 30, 1978)
  • K771489 — RTERIAL BLOOD SAMPLING KIT (August 22, 1977)
  • K771370 — ICROTAINEO BRAND TUBE (August 3, 1977)
  • K760086 — TRAY, BLOOD SAMPLING (PULSATOR II) (July 16, 1976)

FDA data resources