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FDA 510(k)

MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &

K-Number: K851737 · 1985-05-15

ApplicantSigma
Decision Date1985-05-15
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES & is the device name listed in this FDA 510(k) record. The listed applicant is Sigma. It received FDA 510(k) clearance on 1985-05-15 under 510(k) number K851737. 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 MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &?

MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES & is a medical device that received FDA 510(k) clearance on 1985-05-15. The listed applicant is Sigma. The 510(k) number is K851737.

When did MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES & receive FDA 510(k) clearance?

MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES & received FDA 510(k) clearance on 1985-05-15, under 510(k) number K851737.

Who is the listed applicant for MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &?

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

What is the FDA product code for MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &?

The FDA product code for MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES & is KIT.

Related Clinical Trials

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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Other records listing Sigma 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.

K962239SMART ADJUSTER (SA201)K926191SIGMA 7000 AND SIGMA70002K851738MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &K830038SIGMA 7000-6000 INFUSION PUMPSK820038SIGMA 7000

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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