FDA 510(k)

TRI-LEVEL BILIRUBIN CONTROLS

K-Number: K833898 · 1984-01-13

Decision Date1984-01-13

Product CodeJJX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TRI-LEVEL BILIRUBIN CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Sandare Chemical Co., Inc.. It received FDA 510(k) clearance on 1984-01-13 under 510(k) number K833898. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-LEVEL BILIRUBIN CONTROLS?

TRI-LEVEL BILIRUBIN CONTROLS is a medical device that received FDA 510(k) clearance on 1984-01-13. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K833898.

When did TRI-LEVEL BILIRUBIN CONTROLS receive FDA 510(k) clearance?

TRI-LEVEL BILIRUBIN CONTROLS received FDA 510(k) clearance on 1984-01-13, under 510(k) number K833898.

Who is the listed applicant for TRI-LEVEL BILIRUBIN CONTROLS?

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

What is the FDA product code for TRI-LEVEL BILIRUBIN CONTROLS?

The FDA product code for TRI-LEVEL BILIRUBIN CONTROLS is JJX.

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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.