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FDA 510(k)

RAPID AS LATEX

K-Number: K862530 · 1987-04-21

ApplicantDilab, Inc.
Decision Date1987-04-21
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID AS LATEX is the device name listed in this FDA 510(k) record. The listed applicant is Dilab, Inc.. It received FDA 510(k) clearance on 1987-04-21 under 510(k) number K862530. The device is classified under product code GTQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID AS LATEX?

RAPID AS LATEX is a medical device that received FDA 510(k) clearance on 1987-04-21. The listed applicant is Dilab, Inc.. The 510(k) number is K862530.

When did RAPID AS LATEX receive FDA 510(k) clearance?

RAPID AS LATEX received FDA 510(k) clearance on 1987-04-21, under 510(k) number K862530.

Who is the listed applicant for RAPID AS LATEX?

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

What is the FDA product code for RAPID AS LATEX?

The FDA product code for RAPID AS LATEX is GTQ.

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Other records listing Dilab, 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.

K850931ALBUMINK850932CREATININEK850938CHOLESTEROLK850934PHOSPHORUSK850933URIC ACIDK850936TOTAL PROTEINS

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Related Devices (Code: GTQ)

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.

K052645VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;Ortho-Clinical DiagnosticsK953437OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K915742TURBIQUANT ASLBehring Diagnostics, Inc.K926236BECKMAN ANTI-STREPTOLYSIN O KITBeckman Instruments, Inc.K924247ACCUTEX ASO LATEX TESTJ.S. Medical Assoc.K922723TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROLSimplicity Diagnostics, 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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