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510(k) K800398

PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT by Diagnostica, Inc. — Product Code DEW

K800398 is an FDA 510(k) premarket notification submitted by Diagnostica, Inc. for the device "PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT". The FDA issued a decision of Substantially Equivalent on March 12, 1980. The device falls under product code DEW (Igg, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1980
Date Received
February 26, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
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)
  • K791283 — ANTI-HUMAN LAMBDA SERUM (November 27, 1979)
  • K791284 — ANTI-HUMAN KAPPA SERUM (November 27, 1979)
  • K791281 — ANTI-HUMAN IGG SERUM (November 27, 1979)
  • K791285 — ANTI-HUMAN GLOBULINS (October 17, 1979)
  • K791282 — ANTI-HUMAN SERUM (October 17, 1979)
  • K790671 — DERMATOPHYTIN O (May 31, 1979)
  • K790672 — ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU (May 31, 1979)

Other clearances for product code DEW

  • K050113 — TINA-QUANT IGG GEN.2 (February 8, 2005)
  • K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (March 10, 2004)
  • K010617 — SPIFE IFE CALIBRATOR AND CONTROL KIT (March 15, 2001)
  • K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (January 18, 2000)
  • K993281 — K-ASSAY IGG (November 9, 1999)
  • K983221 — IGG (November 4, 1998)
  • K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (March 6, 1997)
  • K963974 — IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (March 6, 1997)
  • K963868 — IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (February 10, 1997)
  • K962202 — QUANTEX IGG (September 26, 1996)

FDA data resources