FDA 510(k)

MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES

K-Number: K845014 · 1985-02-27

Decision Date1985-02-27

Product CodeKIT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES 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 1985-02-27 under 510(k) number K845014. 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 MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES?

MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES is a medical device that received FDA 510(k) clearance on 1985-02-27. The listed applicant is Sigma Chemical Co.. The 510(k) number is K845014.

When did MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES receive FDA 510(k) clearance?

MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES received FDA 510(k) clearance on 1985-02-27, under 510(k) number K845014.

Who is the listed applicant for MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES?

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 MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES?

The FDA product code for MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES is KIT.

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Related Devices (Code: KIT)

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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.