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FDA 510(k)

BME AUTOCLAVABLE MEDIUM

K-Number: K821915 · 1982-07-27

ApplicantDutchland Laboratories, Inc.
Decision Date1982-07-27
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BME AUTOCLAVABLE MEDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Dutchland Laboratories, Inc.. It received FDA 510(k) clearance on 1982-07-27 under 510(k) number K821915. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BME AUTOCLAVABLE MEDIUM?

BME AUTOCLAVABLE MEDIUM is a medical device that received FDA 510(k) clearance on 1982-07-27. The listed applicant is Dutchland Laboratories, Inc.. The 510(k) number is K821915.

When did BME AUTOCLAVABLE MEDIUM receive FDA 510(k) clearance?

BME AUTOCLAVABLE MEDIUM received FDA 510(k) clearance on 1982-07-27, under 510(k) number K821915.

Who is the listed applicant for BME AUTOCLAVABLE MEDIUM?

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

What is the FDA product code for BME AUTOCLAVABLE MEDIUM?

The FDA product code for BME AUTOCLAVABLE MEDIUM is KIT.

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Other records listing Dutchland Laboratories, 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.

K821912MCCOY'S POWDER MEDIUM 5A SUSPENSIONK821918POWDERED RPMI-1603 MEDIUMK821911S-MEM-JOKLIK'S POWDERK821916IMPROVED MEM-RICHTER'S POWDER MODIF.K821917WAYMOUTH'S POWDER MEDIUMK821913ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM

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Related Devices (Code: KIT)

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.

K892938AMNIO-GROW TMInovar Biologicals, Inc.K890700MELANOCYTE GROWTH MEDIUM (MGM)Clonetics Corp.K890701ENDOTHELIAL GROWTH MEDIUM (EGM)Clonetics Corp.K890482ABC, ABC-1X, ABC(TM)Cell Ent., Inc.K884654ALPHACALF SERUMHyclone Laboratories, Inc.K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382Sigma Chemical Co.

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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