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510(k) K800995

IMMUNOGLOBULIN E TEST KIT by Calbiochem-Behring Corp. — Product Code DGO

K800995 is an FDA 510(k) premarket notification submitted by Calbiochem-Behring Corp. for the device "IMMUNOGLOBULIN E TEST KIT". The FDA issued a decision of Substantially Equivalent on May 14, 1980. The device falls under product code DGO (Ige, Peroxidase, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Calbiochem-Behring Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1980
Date Received
April 25, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ige, Peroxidase, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
PA
Submission Type

Other clearances by Calbiochem-Behring Corp.

  • K831811 — REVOLUTION RADIAL IMMUNODIFFUSION PLATE (July 28, 1983)
  • K831036 — ENA TEST KIT SM & RNP AUTO ANTIBODY (April 27, 1983)
  • K830214 — AFT SYSTEM III (March 9, 1983)
  • K820812 — CREATINE KINASE-MB KIT (April 12, 1982)
  • K813493 — ENZYGNOST TM RUBELLA IGM (March 4, 1982)
  • K820088 — AFT SYSTEM PROFICIENCY TESTING PROGRAM (January 26, 1982)
  • K812458 — PADAC (September 23, 1981)
  • K810669 — PANTRAK E.K. (March 31, 1981)
  • K810718 — C-PEPTICE REAGENTS (March 31, 1981)
  • K810309 — RUBELLA ANTIBODIES TEST REAGENTS (March 11, 1981)

Other clearances for product code DGO

  • K943194 — IMMULITE(R) ALLERGY FOOD PANEL FP5E (February 23, 1995)
  • K920087 — IGE EIA TEST KIT (September 14, 1992)
  • K911511 — ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED (April 17, 1991)
  • K894039 — QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION (July 14, 1989)
  • K893125 — BECKMAN EPSILON(TM) IGE REAGENT KIT (June 16, 1989)
  • K872801 — ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 (September 10, 1987)
  • K860851 — ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM (March 28, 1986)
  • K853607 — ALLERG-E IGE ENZYME IMMUNOASSAY KIT (November 7, 1985)
  • K831984 — POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE (November 21, 1983)
  • K831987 — EPSILON IGE TEST KIT (October 14, 1983)

FDA data resources