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)

TISSUE-TEK III ACCU-CUT ROTARY MICROTOME

K-Number: K812558 · 1981-09-29

ApplicantMiles Laboratories, Inc.
Decision Date1981-09-29
Product CodeIDO
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

TISSUE-TEK III ACCU-CUT ROTARY MICROTOME 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 1981-09-29 under 510(k) number K812558. The device is classified under product code IDO. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TISSUE-TEK III ACCU-CUT ROTARY MICROTOME?

TISSUE-TEK III ACCU-CUT ROTARY MICROTOME is a medical device that received FDA 510(k) clearance on 1981-09-29. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K812558.

When did TISSUE-TEK III ACCU-CUT ROTARY MICROTOME receive FDA 510(k) clearance?

TISSUE-TEK III ACCU-CUT ROTARY MICROTOME received FDA 510(k) clearance on 1981-09-29, under 510(k) number K812558.

Who is the listed applicant for TISSUE-TEK III ACCU-CUT ROTARY MICROTOME?

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 TISSUE-TEK III ACCU-CUT ROTARY MICROTOME?

The FDA product code for TISSUE-TEK III ACCU-CUT ROTARY MICROTOME is IDO.

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: IDO)

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.

K864733LKB 2260 MACROTOMELkb Instruments, Inc.K863548ROTARY MICROTOMESurgipath Medical Industries, Inc.K843505LKB 2230 ROTARY ONELkb Instruments, Inc.K812157LKB-BROMMA 2218 HISTORANGE MICROTOMELkb Instruments, 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.

↑