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FDA 510(k)

BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH

K-Number: K864659 · 1987-02-04

ApplicantBio Mega Diagnostic, Inc.
Decision Date1987-02-04
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH is the device name listed in this FDA 510(k) record. The listed applicant is Bio Mega Diagnostic, Inc.. It received FDA 510(k) clearance on 1987-02-04 under 510(k) number K864659. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH?

BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH is a medical device that received FDA 510(k) clearance on 1987-02-04. The listed applicant is Bio Mega Diagnostic, Inc.. The 510(k) number is K864659.

When did BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH receive FDA 510(k) clearance?

BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH received FDA 510(k) clearance on 1987-02-04, under 510(k) number K864659.

Who is the listed applicant for BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH?

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

What is the FDA product code for BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH?

The FDA product code for BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH is JLW.

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Other records listing Bio Mega Diagnostic, 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.

K822438BIOMEGA MODEL 59WK813556MOD. 587 BLOOD PRESSURE & PULSE MONITORK801923BIOMEGA #423-B BLOOD PRESSURE & PULSE CKK760930BLOOD PRESSURE & PULSE CHECKER

Related Devices (Code: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.

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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