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FDA 510(k)

P-AMYLASE CONTROL

K-Number: K935362 · 1994-01-27

ApplicantBeckman
Decision Date1994-01-27
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

P-AMYLASE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Beckman. It received FDA 510(k) clearance on 1994-01-27 under 510(k) number K935362. 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 P-AMYLASE CONTROL?

P-AMYLASE CONTROL is a medical device that received FDA 510(k) clearance on 1994-01-27. The listed applicant is Beckman. The 510(k) number is K935362.

When did P-AMYLASE CONTROL receive FDA 510(k) clearance?

P-AMYLASE CONTROL received FDA 510(k) clearance on 1994-01-27, under 510(k) number K935362.

Who is the listed applicant for P-AMYLASE CONTROL?

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

What is the FDA product code for P-AMYLASE CONTROL?

The FDA product code for P-AMYLASE CONTROL is JJX.

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Other records listing Beckman 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.

K991707MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206K971534SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROLK904219SYNCHRON CX 7 CLINICAL ANALYZERK904220SYNCHRON CX4-CEK893583BECKMAN CHOLINESTERASE REAGENT KIT

Related Devices (Code: JJX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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