Home / 510(k) Clearances / K790705

510(k) K790705

ANTISERUM TO HUMAN IGM by Kent Laboratories, Inc. — Product Code DAO

K790705 is an FDA 510(k) premarket notification submitted by Kent Laboratories, Inc. for the device "ANTISERUM TO HUMAN IGM". The FDA issued a decision of SESP on April 12, 1979. The device falls under product code DAO (Igm (Mu Chain Specific), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Kent Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESP ()
Decision Date
April 12, 1979
Date Received
April 12, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm (Mu Chain Specific), Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
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 DAO

  • K040431 — ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 (March 10, 2004)
  • K982639 — SPIFE URINE IFE (November 4, 1998)
  • K955908 — BOEHRINGER MANNHEIM IGM ASSAY (February 9, 1996)
  • K850586 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M (March 14, 1985)
  • K841992 — MODIFICATION TO ACS CORONARY GUIDING (June 11, 1984)
  • K812487 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM (September 23, 1981)
  • K800450 — GEMENI IGM ASSAY (April 24, 1980)

FDA data resources