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510(k) K811374

BI-CRP LATEX TEST by Biologics Intl., Inc. — Product Code DCN

K811374 is an FDA 510(k) premarket notification submitted by Biologics Intl., Inc. for the device "BI-CRP LATEX TEST". The FDA issued a decision of Substantially Equivalent on June 12, 1981. The device falls under product code DCN (System, Test, C-Reactive Protein), a Class II device regulated under 21 CFR 866.5270. Biologics Intl., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1981
Date Received
May 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Biologics Intl., Inc.

  • K882229 — AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS (August 16, 1988)
  • K823353 — CARCINO-CEK (December 14, 1982)
  • K812060 — BI-ASO SLIDE TEST (August 13, 1981)
  • K811375 — BI-RA SLIDE TEST (June 12, 1981)
  • K800605 — ANA LATEX SLIDE TEST (April 2, 1980)
  • K791609 — BE-SURE (October 2, 1979)
  • K791607 — BETA-CELL (September 24, 1979)
  • K790898 — PREG-TEX (July 30, 1979)

Other clearances for product code DCN

  • K232624 — CardioPhase® hsCRP (November 27, 2023)
  • K221119 — RCRP Flex reagent cartridge (March 17, 2023)
  • K192072 — Tina-quant C-Reactive Protein IV (February 21, 2020)
  • K180099 — Optilite High Sensitivity C-Reactive Protein Kit (October 12, 2018)
  • K172868 — Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optil (February 28, 2018)
  • K171498 — MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (January 12, 2018)
  • K161982 — C-Reactive Protein Kit for use on SPAPLUS (April 5, 2017)
  • K113809 — HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (August 17, 2012)
  • K091052 — PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (January 15, 2010)
  • K083444 — C-REACTIVE PROTEIN (LATEX) (March 18, 2009)

FDA data resources