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510(k) K951749

BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 by Biocell Laboratories, Inc. — Product Code JJY

K951749 is an FDA 510(k) premarket notification submitted by Biocell Laboratories, Inc. for the device "BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3". The FDA issued a decision of Substantially Equivalent on May 15, 1995. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Biocell Laboratories, Inc. has 5 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1995
Date Received
Apr 17, 1995
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 Biocell Laboratories, Inc.

  • K000056 — BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS (Feb 24, 2000)
  • K963551 — BIO-CSF LIQUID CONTROL LEVEL 1 AND 2 (Oct 7, 1996)
  • K844344 — GEMCAL ENI REFERENCE SERUM (Jan 3, 1985)
  • K830911 — RADIAL IMMUNODIFFUSION PLATES (Jun 10, 1983)
  • K830179 — BIOCELL SPINAL FLUID CONTROL (Feb 18, 1983)

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 K951749. Report a data issue: hello@regdatalab.com.