Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SERALYZER REFLECTANCE PHOTOMETER/CALIB.

K-Number: K800524 · 1980-04-02

ApplicantMiles Laboratories, Inc.
Decision Date1980-04-02
Product CodeCIE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERALYZER REFLECTANCE PHOTOMETER/CALIB. is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1980-04-02 under 510(k) number K800524. The device is classified under product code CIE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERALYZER REFLECTANCE PHOTOMETER/CALIB.?

SERALYZER REFLECTANCE PHOTOMETER/CALIB. is a medical device that received FDA 510(k) clearance on 1980-04-02. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K800524.

When did SERALYZER REFLECTANCE PHOTOMETER/CALIB. receive FDA 510(k) clearance?

SERALYZER REFLECTANCE PHOTOMETER/CALIB. received FDA 510(k) clearance on 1980-04-02, under 510(k) number K800524.

Who is the listed applicant for SERALYZER REFLECTANCE PHOTOMETER/CALIB.?

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

What is the FDA product code for SERALYZER REFLECTANCE PHOTOMETER/CALIB.?

The FDA product code for SERALYZER REFLECTANCE PHOTOMETER/CALIB. is CIE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Miles Laboratories, 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.

K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK874909MICRO-BUMINTEST REAGENT TABLETSK875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

View all 158 devices →

Related Devices (Code: CIE)

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.

K904761P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENTInstrumentation Laboratory COK880967MICRO CO2 APPARATUSHf Scientific, Inc.K864313CO2 REAGENT SETHf Scientific, Inc.K832071TOTAL CO2 REAGENT SETAmerican Research Products Co.K820091AIRMED SMOKE EVACUATION & FILTERJames L. Geraci & Associates, Inc.K771610CARBON DIOXIDE ANALYZERCorning Medical & Scientific

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.

↑