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510(k) K885298

VISUWELL REAGIN TEST 960 TEST KIT by Allelix Diagnostics, Inc. — Product Code GMP

K885298 is an FDA 510(k) premarket notification submitted by Allelix Diagnostics, Inc. for the device "VISUWELL REAGIN TEST 960 TEST KIT". The FDA issued a decision of Substantially Equivalent on March 15, 1989. The device falls under product code GMP (Antisera, Control For Nontreponemal Tests), a Class II device regulated under 21 CFR 866.3820. Allelix Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1989
Date Received
December 27, 1988
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 Allelix Diagnostics, Inc.

  • K880665 — MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT (March 1, 1988)

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)
  • K875180 — V-TREND RPRL CARD TEST (February 4, 1988)
  • K851504 — VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 (August 19, 1985)
  • K843741 — RPR TEST REDITEST (October 25, 1984)
  • K812425 — BECKMAN R.PR CONTROL SERUM SET (September 23, 1981)
  • K810119 — CONTROL SERUMS FOR NONTREPONEMAL TEST (February 9, 1981)

FDA data resources