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Biocell Laboratories, Inc.

FDA Regulatory Profile

Biocell Laboratories, Inc. has 0 FDA recalls, 4 inspections, 6 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Biocell Laboratories, Inc." and its spelling variant "Biocell Laboratories".

Latest inspection: Sep 24, 2019 · NAI
Latest 510(k): Feb 24, 2000

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	6	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

Recent FDA inspections

4 inspections from Feb 12, 2010 to Sep 24, 2019.

Date	Site	Product	Classification	FEI
Sep 24, 2019	Rancho Dominguez, CA	Devices	No Action Indicated (NAI)	2077563
Aug 7, 2015	Rancho Dominguez, CA	Devices	No Action Indicated (NAI)	2077563
Jul 26, 2011	Rancho Dominguez, CA	Devices	No Action Indicated (NAI)	2077563
Feb 12, 2010	Rancho Dominguez, CA	Devices	No Action Indicated (NAI)	2077563

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 2077563	Rancho Dominguez, CA	4	Sep 24, 2019

Recent 510(k) clearances

6 510(k) clearances from Feb 18, 1983 to Feb 24, 2000.

K-Number	Device	Date
K000056	BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS	Feb 24, 2000
K963551	BIO-CSF LIQUID CONTROL LEVEL 1 AND 2	Oct 7, 1996
K951749	BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3	May 15, 1995
K844344	GEMCAL ENI REFERENCE SERUM	Jan 3, 1985
K830911	RADIAL IMMUNODIFFUSION PLATES	Jun 10, 1983
K830179	BIOCELL SPINAL FLUID CONTROL	Feb 18, 1983

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