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FDA 510(k)

DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR

K-Number: K850719 · 1985-03-22

ApplicantRapid City Regional Hospital, Inc.
Decision Date1985-03-22
Product CodeJSH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR is the device name listed in this FDA 510(k) record. The listed applicant is Rapid City Regional Hospital, Inc.. It received FDA 510(k) clearance on 1985-03-22 under 510(k) number K850719. 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 TEST MEDIA, CHRISTENSEN'S UREA AGAR?

DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR is a medical device that received FDA 510(k) clearance on 1985-03-22. The listed applicant is Rapid City Regional Hospital, Inc.. The 510(k) number is K850719.

When did DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR receive FDA 510(k) clearance?

DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR received FDA 510(k) clearance on 1985-03-22, under 510(k) number K850719.

Who is the listed applicant for DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR?

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

What is the FDA product code for DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR?

The FDA product code for DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR is JSH.

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Other records listing Rapid City Regional Hospital, 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.

K850724CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIALK850716SELENITE F BROTHK850720EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5%K850722MARTIN LEWIS AGARK850717AMIES TRANSPORT MEDIAK850721KLIGER'S IRON AGAR, SIM MEDIA, MRVP MEDIUM, BILE E

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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.

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