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FDA 510(k)

WALLENSTEIN MEDIUM SLANT

K-Number: K880138 · 1988-03-30

ApplicantHardy Media
Decision Date1988-03-30
Product CodeKZI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

WALLENSTEIN MEDIUM SLANT is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Media. It received FDA 510(k) clearance on 1988-03-30 under 510(k) number K880138. The device is classified under product code KZI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALLENSTEIN MEDIUM SLANT?

WALLENSTEIN MEDIUM SLANT is a medical device that received FDA 510(k) clearance on 1988-03-30. The listed applicant is Hardy Media. The 510(k) number is K880138.

When did WALLENSTEIN MEDIUM SLANT receive FDA 510(k) clearance?

WALLENSTEIN MEDIUM SLANT received FDA 510(k) clearance on 1988-03-30, under 510(k) number K880138.

Who is the listed applicant for WALLENSTEIN MEDIUM SLANT?

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

What is the FDA product code for WALLENSTEIN MEDIUM SLANT?

The FDA product code for WALLENSTEIN MEDIUM SLANT is KZI.

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Other records listing Hardy Media 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.

K880134MIDDLEBROOK 7H11 AGARK880122MIDDLEBROOK 7H9 BROTHK880131LOWENSTEIN-JENSEN, GRUFTK880133MIL MEDIUMK880126LAURYL TRYPTOSE BROTHK880116MRVP BROTH

View all 114 devices →

Related Devices (Code: KZI)

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.

K884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)Oxoid U.S.A., Inc.K881995DIAMOND'S MEDIUM MODIFIEDRemel Co.K880122MIDDLEBROOK 7H9 BROTHHardy MediaK880131LOWENSTEIN-JENSEN, GRUFTHardy MediaK880134MIDDLEBROOK 7H11 AGARHardy MediaK880109CYSTINE TRYPTIC MEDIUM BASEHardy Media

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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