Home / 510(k) Clearances / K890576

510(k) K890576

KENLOR HUMAN SPINAL FLUID CONTROL LIQUID by Kenlor Industries, Inc. — Product Code JJY

K890576 is an FDA 510(k) premarket notification submitted by Kenlor Industries, Inc. for the device "KENLOR HUMAN SPINAL FLUID CONTROL LIQUID". The FDA issued a decision of Substantially Equivalent on Mar 9, 1989. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Kenlor Industries, Inc. has 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 9, 1989
Date Received
Feb 6, 1989
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
510(k) Exempt

Other clearances by Kenlor Industries, Inc.

  • K964014 — KENLOR H. PYLORI CONTROL SERUM (Mar 3, 1997)
  • K952840 — KENLOR LIQUID TOTAL URINE CONTROL (Jul 19, 1995)
  • K950326 — KENLOR HUMAN SPINAL FLUID CONTROL (Mar 20, 1995)
  • K903338 — KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL (Sep 7, 1990)
  • K896440 — KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT (Feb 16, 1990)
  • K890618 — COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT (May 22, 1989)
  • K890573 — KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT (Mar 24, 1989)
  • K890577 — KENLOR LIQUID URINE CONTROL (Mar 9, 1989)

Other clearances for product code JJY

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

FDA data resources

Source: FDA 510(k) database entry for K890576. Report a data issue: hello@regdatalab.com.