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FDA 510(k)

ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8

K-Number: K871150 · 1987-05-26

ApplicantBeckman Instruments, Inc.
Decision Date1987-05-26
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8 is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1987-05-26 under 510(k) number K871150. 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 ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8?

ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8 is a medical device that received FDA 510(k) clearance on 1987-05-26. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K871150.

When did ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8 receive FDA 510(k) clearance?

ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8 received FDA 510(k) clearance on 1987-05-26, under 510(k) number K871150.

Who is the listed applicant for ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8?

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

What is the FDA product code for ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8?

The FDA product code for ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8 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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