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510(k) K875180

V-TREND RPRL CARD TEST by Texas Immunology, Inc. — Product Code GMP

K875180 is an FDA 510(k) premarket notification submitted by Texas Immunology, Inc. for the device "V-TREND RPRL CARD TEST". The FDA issued a decision of Substantially Equivalent on February 4, 1988. The device falls under product code GMP (Antisera, Control For Nontreponemal Tests), a Class II device regulated under 21 CFR 866.3820. Texas Immunology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1988
Date Received
December 17, 1987
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 Texas Immunology, Inc.

  • K991465 — DRUG STOP (December 10, 1999)
  • K980153 — DRUG CHECK (March 27, 1998)
  • K973208 — FIRST SIGN (October 20, 1997)
  • K972094 — TARGET CARDIAC TROPONIN I TEST (July 23, 1997)
  • K963680 — TARGET MYOGLOBIN TEST (February 6, 1997)
  • K912246 — TARGET MICROALBUMINURIA TEST (July 19, 1991)
  • K910073 — TARGET ASO TEST (May 21, 1991)
  • K904105 — V-TREND TARGET RF TEST (October 15, 1990)
  • K892231 — V-TREND TARGET CRP TEST (April 21, 1989)
  • K890423 — V-TREND TARGET CRP TEST (February 17, 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)
  • 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