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510(k) K771243

ANTISERA TO HUMAN FAB FRAGMENT by Kent Laboratories, Inc. — Product Code DFK

K771243 is an FDA 510(k) premarket notification submitted by Kent Laboratories, Inc. for the device "ANTISERA TO HUMAN FAB FRAGMENT". The FDA issued a decision of Substantially Equivalent on August 3, 1977. The device falls under product code DFK (Igg (Fab Fragment Specific), Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5520. Kent Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1977
Date Received
July 11, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg (Fab Fragment Specific), Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5520
Review Panel
IM
Submission Type

Other clearances by Kent Laboratories, Inc.

  • K951966 — HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT (June 1, 1995)
  • K951967 — HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K951968 — HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K950102 — HUMAN C-5 RADIAL IMMUNODIFFUSION KIT (April 10, 1995)
  • K850683 — 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 (November 27, 1985)
  • K850682 — 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL (November 25, 1985)
  • K850691 — ANTISERUM TO HUMAN APOLIPOPROTEIN A-I (November 1, 1985)
  • K850686 — ANTISERUM TO HUMAN PREALBUMIN (November 1, 1985)
  • K850690 — ANTISERUM TO HUMAN APOLIPOPROTEIN B (November 1, 1985)
  • K831961 — IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN (August 11, 1983)

Other clearances for product code DFK

  • K790711 — ANTISERA TO HUMAN FRAGMENT (September 4, 1979)
  • K770670 — FLOR. CONJUG. HUMAN FAB FRAGMENT (April 28, 1977)

FDA data resources