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FDA 510(k)

#50003 QUAD DIAGNOSTIC SYSTEM

K-Number: K821302 · 1982-06-01

ApplicantBiomedia, Inc.
Decision Date1982-06-01
Product CodeJSH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

#50003 QUAD DIAGNOSTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomedia, Inc.. It received FDA 510(k) clearance on 1982-06-01 under 510(k) number K821302. The device is classified under product code JSH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the #50003 QUAD DIAGNOSTIC SYSTEM?

#50003 QUAD DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1982-06-01. The listed applicant is Biomedia, Inc.. The 510(k) number is K821302.

When did #50003 QUAD DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

#50003 QUAD DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 1982-06-01, under 510(k) number K821302.

Who is the listed applicant for #50003 QUAD DIAGNOSTIC SYSTEM?

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

What is the FDA product code for #50003 QUAD DIAGNOSTIC SYSTEM?

The FDA product code for #50003 QUAD DIAGNOSTIC SYSTEM is JSH.

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Other records listing Biomedia, 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.

K821300#2010 CAMPHYLOBACTER AGARK821301#50002 QUAD DIAGNOSTIC SYSTEMK821108BI PLATE-XLD/HEKTOEN #30012K811473MUELLER HINTON AGAR W/5% SHEEP BLOODK811476THAYER MARTIN AGARK811478EMB AGAR, LEVINE

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Related Devices (Code: JSH)

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.

K881551PHENOL RED BROTH BASEAcumedia Manufacturers, Inc.K881553RUSSELL DOUBLE SUGAR AGARAcumedia Manufacturers, Inc.K881486DNASE TEST AGARAcumedia Manufacturers, Inc.K881540FLO AGARAcumedia Manufacturers, Inc.K881559UREA AGAR BASEAcumedia Manufacturers, Inc.K881560UREA BROTHAcumedia 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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