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510(k) K792705

PARA-PAK FORMALIN by Meridian Diagnostics, Inc. — Product Code IGG

K792705 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "PARA-PAK FORMALIN". The FDA issued a decision of Substantially Equivalent on January 21, 1980. The device falls under product code IGG (Formaldehyde (Formalin, Formol)), a Class I device regulated under 21 CFR 864.4010. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1980
Date Received
December 27, 1979
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 Meridian Diagnostics, Inc.

  • K993914 — PREMIER TOXINS A&B, MODEL 616096 (December 10, 1999)
  • K990263 — IMMUNOCARD STAT! E. COLI O157:H7 (August 9, 1999)
  • K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST (June 25, 1999)
  • K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (June 25, 1999)
  • K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA (December 17, 1998)
  • K982764 — PREMIER CRYPTOSPORIDIUM (December 3, 1998)
  • K982711 — PREMIER GIARDIA (November 25, 1998)
  • K980076 — PREMIER PLATINUM HPSA (May 12, 1998)
  • K980077 — PARA-PAK SPINCON (April 2, 1998)
  • K971585 — IMMUNOCARD STAT! ROTAVIRUS (August 20, 1997)

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)
  • K771201 — FORMALIN BUFFER CONCENTRATE (August 22, 1977)

FDA data resources