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FDA 510(k)

BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3

K-Number: K951749 · 1995-05-15

ApplicantBiocell Laboratories, Inc.
Decision Date1995-05-15
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 is the device name listed in this FDA 510(k) record. The listed applicant is Biocell Laboratories, Inc.. It received FDA 510(k) clearance on 1995-05-15 under 510(k) number K951749. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3?

BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 is a medical device that received FDA 510(k) clearance on 1995-05-15. The listed applicant is Biocell Laboratories, Inc.. The 510(k) number is K951749.

When did BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 receive FDA 510(k) clearance?

BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 received FDA 510(k) clearance on 1995-05-15, under 510(k) number K951749.

Who is the listed applicant for BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3?

The FDA 510(k) record lists Biocell Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3?

The FDA product code for BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 is JJY.

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Other records listing Biocell Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K000056BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORSK963551BIO-CSF LIQUID CONTROL LEVEL 1 AND 2K844344GEMCAL ENI REFERENCE SERUMK830911RADIAL IMMUNODIFFUSION PLATESK830179BIOCELL SPINAL FLUID CONTROL

Related Devices (Code: JJY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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