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510(k) K810119

CONTROL SERUMS FOR NONTREPONEMAL TEST by Hillside Acres, Inc. — Product Code GMP

K810119 is an FDA 510(k) premarket notification submitted by Hillside Acres, Inc. for the device "CONTROL SERUMS FOR NONTREPONEMAL TEST". The FDA issued a decision of Substantially Equivalent on February 9, 1981. The device falls under product code GMP (Antisera, Control For Nontreponemal Tests), a Class II device regulated under 21 CFR 866.3820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1981
Date Received
January 16, 1981
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 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)
  • K843741 — RPR TEST REDITEST (October 25, 1984)
  • K812425 — BECKMAN R.PR CONTROL SERUM SET (September 23, 1981)

FDA data resources