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510(k) K761183

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

K761183 is an FDA 510(k) premarket notification submitted by Central Labs. Assoc. MD Pathologists for the device "LYSING AGENT AF". The FDA issued a decision of Substantially Equivalent on January 17, 1977. The device falls under product code JCE (Solution, Isotonic), a Class I device regulated under 21 CFR 864.4010. Central Labs. Assoc. MD Pathologists has at least 2 other 510(k) clearances on record.

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

FDA data resources