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510(k) K843741

RPR TEST REDITEST by Biokit USA, Inc. — Product Code GMP

K843741 is an FDA 510(k) premarket notification submitted by Biokit USA, Inc. for the device "RPR TEST REDITEST". The FDA issued a decision of Substantially Equivalent on October 25, 1984. The device falls under product code GMP (Antisera, Control For Nontreponemal Tests), a Class II device regulated under 21 CFR 866.3820. Biokit USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1984
Date Received
September 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Control For Nontreponemal Tests
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type

Other clearances by Biokit USA, Inc.

  • K913467 — TOXOGEN (January 11, 1993)
  • K910541 — BIOKIT RPR (October 18, 1991)
  • K904310 — RHEUMAGEN RF T-CONTROL (May 31, 1991)
  • K910539 — RHEUMAJET RF (April 5, 1991)
  • K910686 — RHEUMAJET CRP (March 19, 1991)
  • K904311 — RHEUMAGEN ASO T-CONTROL (January 25, 1991)
  • K904312 — RHEUMAGEN CRP T-CONTROL (October 1, 1990)
  • K896433 — MODIFIED RUBAGEN (November 29, 1989)
  • K896271 — QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) (November 8, 1989)
  • K896272 — QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL (November 8, 1989)

Other clearances for product code GMP

  • K980638 — ADI SYPHILIS RPR LIQUID CONTROLS (July 6, 1998)
  • K961998 — QUALITROL SYPHSERO CONTROL SET (August 8, 1996)
  • K955143 — RPR LIQUID CONTROLS (July 30, 1996)
  • K885298 — VISUWELL REAGIN TEST 960 TEST KIT (March 15, 1989)
  • K875180 — V-TREND RPRL CARD TEST (February 4, 1988)
  • K851504 — VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 (August 19, 1985)
  • K812425 — BECKMAN R.PR CONTROL SERUM SET (September 23, 1981)
  • K810119 — CONTROL SERUMS FOR NONTREPONEMAL TEST (February 9, 1981)

FDA data resources