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FDA 510(k)

PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM

K-Number: K862674 · 1986-08-15

ApplicantHybritech, Inc.
Decision Date1986-08-15
Product CodeJZT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1986-08-15 under 510(k) number K862674. 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 PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM?

PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM is a medical device that received FDA 510(k) clearance on 1986-08-15. The listed applicant is Hybritech, Inc.. The 510(k) number is K862674.

When did PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM receive FDA 510(k) clearance?

PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM received FDA 510(k) clearance on 1986-08-15, under 510(k) number K862674.

Who is the listed applicant for PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM?

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

What is the FDA product code for PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM?

The FDA product code for PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM is JZT.

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Other records listing Hybritech, Inc. 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.

K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYK961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK922754TANDEM-E IGE II CALIBRATION VERIFICATION SETK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOK921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

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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 PreanalyticK882677STAT-20 FLUOROMETERWeaver MedicalK864699FLUORESCENCE CONCENTRATION ANALYZER (FCA)Pandex Laboratories, Inc.K863434THE FIAX 5000 FLUOROMETERWhittaker Bioproducts, 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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