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510(k) K761183

LYSING AGENT AF by Central Labs. Assoc. MD Pathologists — Product Code JCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1977
Date Received
December 2, 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 Central Labs. Assoc. MD Pathologists

  • K771201 — FORMALIN BUFFER CONCENTRATE (August 22, 1977)
  • K761182 — ISOTONIC DILUENT AF (December 9, 1976)

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)
  • K761170 — BARBITAL SALINE BUFFER (January 10, 1977)
  • K761174 — PHYSIOLOGIC SALINE (0.85%) (January 10, 1977)