FDA 510(k)

ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336

K-Number: K090296 · 2009-02-19

Decision Date2009-02-19

Product CodeKPT

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 is the device name listed in this FDA 510(k) record. The listed applicant is Biodex Medical Systems, Inc.. It received FDA 510(k) clearance on 2009-02-19 under 510(k) number K090296. The device is classified under product code KPT. It was reviewed by the RA advisory panel. Product code KPT falls under the category of In Vitro Diagnostics, which includes laboratory reagents and diagnostic test kits. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336?

ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 is a medical device that received FDA 510(k) clearance on 2009-02-19. The listed applicant is Biodex Medical Systems, Inc.. The 510(k) number is K090296.

When did ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 receive FDA 510(k) clearance?

ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 received FDA 510(k) clearance on 2009-02-19, under 510(k) number K090296.

Who is the listed applicant for ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336?

The FDA 510(k) record lists Biodex Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336?

The FDA product code for ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 is KPT. This falls under the In Vitro Diagnostics category.

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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.