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510(k) K810906

TRI-LEVEL NDI CONTROL by Nuclear Diagnostics, Inc. — Product Code JJY

K810906 is an FDA 510(k) premarket notification submitted by Nuclear Diagnostics, Inc. for the device "TRI-LEVEL NDI CONTROL". The FDA issued a decision of Substantially Equivalent on April 14, 1981. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Nuclear Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1981
Date Received
April 3, 1981
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 Nuclear Diagnostics, Inc.

  • K021656 — HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 (June 13, 2002)
  • K002782 — HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION (December 5, 2000)
  • K923917 — ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY (February 25, 1994)
  • K932406 — NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT (December 2, 1993)
  • K872177 — TIPSEP-CORTISOL RIA DIAGNOSTIC KIT (June 17, 1987)
  • K862312 — ENZLIPASE, ENZYMATIC LIPASE KIT (September 26, 1986)
  • K860472 — NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS (July 3, 1986)
  • K861735 — TIPSEP-TBG ASSAY (June 13, 1986)
  • K852291 — TIPSEP DIGOXIN RIA (June 25, 1985)
  • K833713 — SERUM THYROTROPIN ASSAY KIT, TIPSEP- (December 29, 1983)

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