Home / 510(k) Clearances / K821558

510(k) K821558

LEVEL II CONTROL SERUM by Irvine Scientific — Product Code JJX

K821558 is an FDA 510(k) premarket notification submitted by Irvine Scientific for the device "LEVEL II CONTROL SERUM". The FDA issued a decision of Substantially Equivalent on July 2, 1982. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Irvine Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1982
Date Received
May 25, 1982
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 Irvine Scientific

  • K160006 — Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit (May 4, 2016)
  • K914541 — SPERM MAINTENANCE MEDIUM WITH GLYCEROL (February 3, 1994)
  • K900316 — MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES (April 16, 1990)
  • K894432 — MODIFIED HAM'S F-10 W/ALBUMIN (September 22, 1989)
  • K894405 — HTF WITH ALBUMIN (CATALOG NO. 9994) (September 22, 1989)
  • K874668 — SPERM WASHING MEDIUM #9983 & MODIFIED #9984 (March 31, 1988)
  • K872203 — CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) (August 14, 1987)
  • K872088 — FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) (August 14, 1987)
  • K872102 — SPERM WASHING MEDIUM #9932 (July 16, 1987)
  • K871577 — HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES (July 15, 1987)

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