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510(k) K821557

LEVEL I CONTROL SERUM by Irvine Scientific — Product Code JJY

K821557 is an FDA 510(k) premarket notification submitted by Irvine Scientific for the device "LEVEL I CONTROL SERUM". The FDA issued a decision of Substantially Equivalent on July 8, 1982. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), 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 8, 1982
Date Received
May 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
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)
  • K872088 — FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) (August 14, 1987)
  • K872203 — CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) (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 JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)

FDA data resources