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510(k) K791283

ANTI-HUMAN LAMBDA SERUM by Diagnostica, Inc. — Product Code DEH

K791283 is an FDA 510(k) premarket notification submitted by Diagnostica, Inc. for the device "ANTI-HUMAN LAMBDA SERUM". The FDA issued a decision of Substantially Equivalent on November 27, 1979. The device falls under product code DEH (Lambda, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1979
Date Received
July 10, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lambda, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

Other clearances by Diagnostica, Inc.

  • K002756 — EASE-A-CULT (February 23, 2001)
  • K823348 — H. INFLUENZA B ANTISERA FOR CIE (December 28, 1982)
  • K812434 — DIAGNOSTIC KITS & KIT COMPONENTS (September 23, 1981)
  • K800398 — PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT (March 12, 1980)
  • K791284 — ANTI-HUMAN KAPPA SERUM (November 27, 1979)
  • K791281 — ANTI-HUMAN IGG SERUM (November 27, 1979)
  • K791282 — ANTI-HUMAN SERUM (October 17, 1979)
  • K791285 — ANTI-HUMAN GLOBULINS (October 17, 1979)
  • K790671 — DERMATOPHYTIN O (May 31, 1979)
  • K790672 — ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU (May 31, 1979)

Other clearances for product code DEH

  • K172471 — VENTANA CD30 (Ber-H2) RxDx Assay (May 8, 2018)
  • K140396 — FREELITE HUMAN LAMBDA FREE KIT (April 16, 2014)
  • K083601 — LAMBDA LIGHT CHAINS (June 22, 2009)
  • K033811 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER (January 30, 2004)
  • K031016 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETE (July 15, 2003)
  • K023131 — FREELITE HUMAN LAMBDA FREE KIT (January 21, 2003)
  • K010440 — FREELITE LAMBDA FREE KIT (April 26, 2001)
  • K010441 — FREELITE KAPPA FREE KIT (April 26, 2001)
  • K003671 — LAMBDA IMMAGE FREELITE KIT (February 1, 2001)
  • K002563 — SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (October 26, 2000)

FDA data resources