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FDA 510(k)

DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM)

K-Number: K870496 · 1987-03-30

ApplicantSigma Chemical Co.
Decision Date1987-03-30
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1987-03-30 under 510(k) number K870496. 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 DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM)?

DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM) is a medical device that received FDA 510(k) clearance on 1987-03-30. The listed applicant is Sigma Chemical Co.. The 510(k) number is K870496.

When did DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM) receive FDA 510(k) clearance?

DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM) received FDA 510(k) clearance on 1987-03-30, under 510(k) number K870496.

Who is the listed applicant for DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM)?

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

What is the FDA product code for DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM)?

The FDA product code for DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM) is KIT.

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Other records listing Sigma Chemical Co. 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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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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