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FDA 510(k)

CARIESCREEN LB

K-Number: K871264 · 1987-05-07

ApplicantApo Diagnostics, Inc.
Decision Date1987-05-07
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CARIESCREEN LB is the device name listed in this FDA 510(k) record. The listed applicant is Apo Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-05-07 under 510(k) number K871264. The device is classified under product code JSJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARIESCREEN LB?

CARIESCREEN LB is a medical device that received FDA 510(k) clearance on 1987-05-07. The listed applicant is Apo Diagnostics, Inc.. The 510(k) number is K871264.

When did CARIESCREEN LB receive FDA 510(k) clearance?

CARIESCREEN LB received FDA 510(k) clearance on 1987-05-07, under 510(k) number K871264.

Who is the listed applicant for CARIESCREEN LB?

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

What is the FDA product code for CARIESCREEN LB?

The FDA product code for CARIESCREEN LB is JSJ.

Related Clinical Trials

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Related Devices (Code: JSJ)

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.

K882463POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421Lakewood Biochemical Co., Inc.K881544LITTMAN AGARAcumedia Manufacturers, Inc.K881561TERGITOL 7 BROTHAcumedia Manufacturers, Inc.K881526CHAPMAN STONE MEDIUMAcumedia Manufacturers, Inc.K881571YM BROTHAcumedia Manufacturers, Inc.K881578STREPTOSELAcumedia Manufacturers, Inc.

Official Source

View on FDA Database →

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

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