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510(k) K881430

LIQUI-SERA SERUM ALCOHOL CONTROLS by Biodiagnostic Intl — Product Code JJX

K881430 is an FDA 510(k) premarket notification submitted by Biodiagnostic Intl for the device "LIQUI-SERA SERUM ALCOHOL CONTROLS". The FDA issued a decision of Substantially Equivalent on July 8, 1988. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Biodiagnostic Intl has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1988
Date Received
April 5, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Biodiagnostic Intl

  • K031296 — LIQUI-HEME GLYCO A1C ASSAY (October 15, 2004)
  • K874459 — LIQUI-SERA SPINAL FLUID CONTROL (December 29, 1987)
  • K863849 — LIQUI-SERA COMBO LIGAND/TDM CONTROLS (November 24, 1986)
  • K853906 — LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) (October 4, 1985)
  • K853887 — LIQUI-SERA CHEM. MULTIPLE CALIBRATORS (September 30, 1985)
  • K842668 — LIQUI-HEME HEMOGLOBIN CALIBRATORS (March 5, 1985)
  • K840618 — LIQUI-URA CHEMISTRY URINE CONTROLS (April 4, 1984)
  • K834398 — LIQUI-SERA TDM CALIBRATORS (February 3, 1984)
  • K834259 — LIQUI-URA TOXIC URINE CONTROL (January 30, 1984)
  • K831278 — LIQUI-SERA ANTICONVULSANTS CONTROLS (May 27, 1983)

Other clearances for product code JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (April 4, 2017)
  • K162173 — Elecsys CYFRA 21-1 CalCheck 5 (January 12, 2017)
  • K162514 — Multichem A1c (October 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (June 30, 2016)
  • K161526 — LIAISON CMV IgM Serum Control Set (June 30, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K152117 — Dropper hsCRP High Sensitivity CRP Control (April 21, 2016)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Ce (July 17, 2015)

FDA data resources