FDA 510(k)

DULBECCOS PHOSPHATE BUFFERED SALINE

K-Number: K832835 · 1983-09-29

Decision Date1983-09-29

Product CodeKIT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

DULBECCOS PHOSPHATE BUFFERED SALINE 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 1983-09-29 under 510(k) number K832835. 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 DULBECCOS PHOSPHATE BUFFERED SALINE?

DULBECCOS PHOSPHATE BUFFERED SALINE is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Sigma Chemical Co.. The 510(k) number is K832835.

When did DULBECCOS PHOSPHATE BUFFERED SALINE receive FDA 510(k) clearance?

DULBECCOS PHOSPHATE BUFFERED SALINE received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832835.

Who is the listed applicant for DULBECCOS PHOSPHATE BUFFERED SALINE?

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 DULBECCOS PHOSPHATE BUFFERED SALINE?

The FDA product code for DULBECCOS PHOSPHATE BUFFERED SALINE is KIT.

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Other records listing Sigma Chemical Co. as applicant

K933694SIGMA GLUCOSE REAGENT K933678SIGMA CALCIUM REAGENT K933696SIGMA ELECTROLYTE REFERENCE REAGENT K933691SIGMA CO2 ALKALINE BUFFER REAGENT K933679SIGMA BUN REAGENT K933703SIGMA WASH CONCENTRATE SOLUTION

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Related Devices (Code: KIT)

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.