Home / 510(k) Clearances / K861202

510(k) K861202

TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS by Nms Pharmaceuticals, Inc. — Product Code JJY

K861202 is an FDA 510(k) premarket notification submitted by Nms Pharmaceuticals, Inc. for the device "TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS". The FDA issued a decision of Substantially Equivalent on January 9, 1987. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Nms Pharmaceuticals, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1987
Date Received
March 31, 1986
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 Nms Pharmaceuticals, Inc.

  • K854236 — HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS (October 10, 1986)
  • K860828 — FORETEL, COLOR OVULATION TEST (August 4, 1986)
  • K853925 — QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA (December 2, 1985)
  • K851445 — COLOR OVULATION TEST (July 29, 1985)
  • K850431 — EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL (June 17, 1985)
  • K850786 — TOTAL HIGE ENZYME IMMUNOASSAY (April 12, 1985)
  • K850787 — SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY (March 26, 1985)
  • K842499 — NMS 1043 ENZYME IMMUNOASSAY KIT (September 14, 1984)

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