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FDA 510(k)

DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)

K-Number: K061818 · 2006-07-18

ApplicantDade Behring, Inc.
Decision Date2006-07-18
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2006-07-18 under 510(k) number K061818. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)?

DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) is a medical device that received FDA 510(k) clearance on 2006-07-18. The listed applicant is Dade Behring, Inc.. The 510(k) number is K061818.

When did DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) receive FDA 510(k) clearance?

DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) received FDA 510(k) clearance on 2006-07-18, under 510(k) number K061818.

Who is the listed applicant for DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)?

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

What is the FDA product code for DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)?

The FDA product code for DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) is JIT.

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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.

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