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FDA 510(k)

STAT-20 FLUOROMETER

K-Number: K882677 · 1988-07-12

ApplicantWeaver Medical
Decision Date1988-07-12
Product CodeJZT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

STAT-20 FLUOROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Weaver Medical. It received FDA 510(k) clearance on 1988-07-12 under 510(k) number K882677. The device is classified under product code JZT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT-20 FLUOROMETER?

STAT-20 FLUOROMETER is a medical device that received FDA 510(k) clearance on 1988-07-12. The listed applicant is Weaver Medical. The 510(k) number is K882677.

When did STAT-20 FLUOROMETER receive FDA 510(k) clearance?

STAT-20 FLUOROMETER received FDA 510(k) clearance on 1988-07-12, under 510(k) number K882677.

Who is the listed applicant for STAT-20 FLUOROMETER?

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

What is the FDA product code for STAT-20 FLUOROMETER?

The FDA product code for STAT-20 FLUOROMETER is JZT.

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Related Devices (Code: JZT)

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.

K962499ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READERBartels, Inc.K883349QLIA IMMUNOCHEMISTRY SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK864699FLUORESCENCE CONCENTRATION ANALYZER (FCA)Pandex Laboratories, Inc.K863434THE FIAX 5000 FLUOROMETERWhittaker Bioproducts, Inc.K862674PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEMHybritech, Inc.K852240SMS, SCREEN MACHINE SYSTEMPandex Laboratories, Inc.

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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