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510(k) K771201

FORMALIN BUFFER CONCENTRATE by Central Labs. Assoc. MD Pathologists — Product Code IGG

K771201 is an FDA 510(k) premarket notification submitted by Central Labs. Assoc. MD Pathologists for the device "FORMALIN BUFFER CONCENTRATE". The FDA issued a decision of Substantially Equivalent on August 22, 1977. The device falls under product code IGG (Formaldehyde (Formalin, Formol)), 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
August 22, 1977
Date Received
July 5, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formaldehyde (Formalin, Formol)
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Central Labs. Assoc. MD Pathologists

  • K761183 — LYSING AGENT AF (January 17, 1977)
  • K761182 — ISOTONIC DILUENT AF (December 9, 1976)

Other clearances for product code IGG

  • K882268 — ZINC FORMALIN CONCENTRATE (June 15, 1988)
  • K861201 — FORMALDEHYDE SOLUTION, 37% (April 11, 1986)
  • K811794 — 37% FORMALDEHYDE (July 28, 1981)
  • K802506 — PLEASCENT OR FORMA-SCENT (November 12, 1980)
  • K792707 — PARA-PAK SAF (January 21, 1980)
  • K792705 — PARA-PAK FORMALIN (January 21, 1980)

FDA data resources