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510(k) K801854

SPINAL FLUID CONTROL(HUMAN) by Environmental Chemical Specialties — Product Code JJX

K801854 is an FDA 510(k) premarket notification submitted by Environmental Chemical Specialties for the device "SPINAL FLUID CONTROL(HUMAN)". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Environmental Chemical Specialties has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
August 4, 1980
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 Environmental Chemical Specialties

  • K812635 — ANEMIA CONTROL (October 2, 1981)
  • K811810 — URIC ACID TEST (July 15, 1981)
  • K811811 — TDM ANTI-CONVULSANT CONTROL LEVELS I-II (July 10, 1981)
  • K811809 — ANTI-ARRHYTHMIC CONTROL LEVELS I & II (July 10, 1981)
  • K803089 — GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) (January 2, 1981)
  • K792377 — CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL (September 26, 1980)
  • K801061 — TOTAL PROTEIN TEST (July 21, 1980)
  • K792374 — QUANTITATIVE CONTROL URINE I (HUMAN) (December 6, 1979)
  • K792376 — QUANTITATIVE CONTROL URINE II (HUMAN) (December 6, 1979)
  • K792375 — ELEVATED LIPID CONTROL (December 6, 1979)

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)
  • K161526 — LIAISON CMV IgM Serum Control Set (June 30, 2016)
  • K161522 — LIAISON EBV 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