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510(k) K761170

BARBITAL SALINE BUFFER by Bio/Data Corp. — Product Code JCE

K761170 is an FDA 510(k) premarket notification submitted by Bio/Data Corp. for the device "BARBITAL SALINE BUFFER". The FDA issued a decision of Substantially Equivalent on January 10, 1977. The device falls under product code JCE (Solution, Isotonic), a Class I device regulated under 21 CFR 864.4010. 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
Solution, Isotonic
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
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 JCE

  • K842722 — BUFFERED SALINE (September 11, 1984)
  • K831200 — IMMUNOHEMATOLOGICAL SALINE #97139 (May 9, 1983)
  • K801506 — CERTIFIED BLOOD BANK SALINE (July 28, 1980)
  • K792101 — COUITER/CMS ISOTONIC BLOOD BANK SALINE (November 20, 1979)
  • K761183 — LYSING AGENT AF (January 17, 1977)
  • K761174 — PHYSIOLOGIC SALINE (0.85%) (January 10, 1977)

FDA data resources