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510(k) K800789

RUBELLA BIO-BEAD TITRATION KIT by Litton Bionetics — Product Code GOL

K800789 is an FDA 510(k) premarket notification submitted by Litton Bionetics for the device "RUBELLA BIO-BEAD TITRATION KIT". The FDA issued a decision of Substantially Equivalent on June 30, 1980. The device falls under product code GOL (Antigen, Ha (Including Ha Control), Rubella), a Class II device regulated under 21 CFR 866.3510. Litton Bionetics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1980
Date Received
April 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Ha (Including Ha Control), Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
Submission Type

Other clearances by Litton Bionetics

  • K840417 — EBNA ACIF KIT (December 27, 1984)
  • K834443 — ROTAVIRUS BIO-ENZABEAD SCREEN KIT (March 16, 1984)
  • K831343 — CMV RQ BIO-ENZABEAD KIT (August 8, 1983)
  • K822985 — EBV-M KIT (December 3, 1982)
  • K821804 — RUBELLA RQ BIO-ENZABEAD KIT (September 14, 1982)
  • K801721 — HSV BIO-BEAD TITRATION KIT (September 16, 1980)
  • K801720 — TOXO BIO-BEAD TITRATION KIT (September 16, 1980)
  • K801722 — CMV BIO-BEAD TITRATION KIT (September 16, 1980)
  • K791614 — HSV BIO-BEAD SCREEN KIT (November 13, 1979)
  • K791610 — RUBELLA BIO-BEAD SCREEN KIT (November 13, 1979)

Other clearances for product code GOL

  • K841174 — RUBELLA ANTIBODY FLUOROIMMUNOASSAY (June 7, 1984)
  • K834032 — RUBAQUICK DIAGNOSTIC KIT (April 17, 1984)
  • K810309 — RUBELLA ANTIBODIES TEST REAGENTS (March 11, 1981)
  • K802339 — EIA RUBELLA-G (December 18, 1980)
  • K802508 — RUBELISA IGM TEST KIT (December 18, 1980)
  • K802102 — RUBELLA ELISA REAGENTS RUBELLA IGG ANTI (December 18, 1980)
  • K801667 — GAMMA COAT(125 I) RUBELLA ANTIBODY (October 23, 1980)
  • K801098 — ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) (September 16, 1980)
  • K801507 — ANTIGEN CONTROL CELLS (August 20, 1980)
  • K800797 — MACRO-VUE RUBELLA CARD TEST (June 20, 1980)

FDA data resources