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)

HEMACOUNT WRIGHTS STAIN PACK II #55952

K-Number: K821457 · 1982-06-01

ApplicantAccra Laboratories, Inc.
Decision Date1982-06-01
Product CodeIAF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMACOUNT WRIGHTS STAIN PACK II #55952 is the device name listed in this FDA 510(k) record. The listed applicant is Accra Laboratories, Inc.. It received FDA 510(k) clearance on 1982-06-01 under 510(k) number K821457. The device is classified under product code IAF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMACOUNT WRIGHTS STAIN PACK II #55952?

HEMACOUNT WRIGHTS STAIN PACK II #55952 is a medical device that received FDA 510(k) clearance on 1982-06-01. The listed applicant is Accra Laboratories, Inc.. The 510(k) number is K821457.

When did HEMACOUNT WRIGHTS STAIN PACK II #55952 receive FDA 510(k) clearance?

HEMACOUNT WRIGHTS STAIN PACK II #55952 received FDA 510(k) clearance on 1982-06-01, under 510(k) number K821457.

Who is the listed applicant for HEMACOUNT WRIGHTS STAIN PACK II #55952?

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

What is the FDA product code for HEMACOUNT WRIGHTS STAIN PACK II #55952?

The FDA product code for HEMACOUNT WRIGHTS STAIN PACK II #55952 is IAF.

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 Accra 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.

K851493KINYOUN ACID FAST STAIN KITK851494TWO-STEP ACID FAST BACTERIA STAINK843427GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6K843425HARRIS HEMATOXYLIN, MERCURY FREE, ACIDK843428BIOFIXK843426EOSIN Y 1% ALCOHOLIC

View all 20 devices →

Related Devices (Code: IAF)

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.

K890674ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SETSigma Diagnostics, Inc.K890673WRIGHT-GLEMSA STAINSigma Diagnostics, Inc.K854236HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDSNms Pharmaceuticals, Inc.K860793CAMCO STAIN PAKCambridge Chemical Products, Inc.K853241HEMATOLOGY STAIN PACKFisher Scientific Co., LLCK852138WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE SCanyon Diagnostics, 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.

↑