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FDA 510(k)

DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR

K-Number: K853336 · 1985-08-29

ApplicantHardy Media
Decision Date1985-08-29
Product CodeJSH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Media. It received FDA 510(k) clearance on 1985-08-29 under 510(k) number K853336. 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 DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR?

DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR is a medical device that received FDA 510(k) clearance on 1985-08-29. The listed applicant is Hardy Media. The 510(k) number is K853336.

When did DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR receive FDA 510(k) clearance?

DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR received FDA 510(k) clearance on 1985-08-29, under 510(k) number K853336.

Who is the listed applicant for DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR?

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 DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR?

The FDA product code for DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR is JSH.

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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

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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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