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FDA 510(k)

BLOOD CULTURE MEDIA

K-Number: K780615 · 1978-05-04

ApplicantMeda Stat Diagnostics, Inc.
Decision Date1978-05-04
Product CodeJSH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BLOOD CULTURE MEDIA is the device name listed in this FDA 510(k) record. The listed applicant is Meda Stat Diagnostics, Inc.. It received FDA 510(k) clearance on 1978-05-04 under 510(k) number K780615. 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 BLOOD CULTURE MEDIA?

BLOOD CULTURE MEDIA is a medical device that received FDA 510(k) clearance on 1978-05-04. The listed applicant is Meda Stat Diagnostics, Inc.. The 510(k) number is K780615.

When did BLOOD CULTURE MEDIA receive FDA 510(k) clearance?

BLOOD CULTURE MEDIA received FDA 510(k) clearance on 1978-05-04, under 510(k) number K780615.

Who is the listed applicant for BLOOD CULTURE MEDIA?

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

What is the FDA product code for BLOOD CULTURE MEDIA?

The FDA product code for BLOOD CULTURE MEDIA is JSH.

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Other records listing Meda Stat Diagnostics, 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.

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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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