Cleared Traditional

K821457 - HEMACOUNT WRIGHTS STAIN PACK II #55952

K821457 is an FDA 510(k) clearance for HEMACOUNT WRIGHTS STAIN PACK II #55952, manufactured by Accra Laboratories, Inc.. The device is a Class 1 Hematology device with product code IAF cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K821457 · Accra Laboratories, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1982
Decision
15d
Days
Class 1
Risk

K821457 is an FDA 510(k) clearance for the HEMACOUNT WRIGHTS STAIN PACK II #55952. Classified as Wright's Stain (product code IAF), Class I - General Controls.

Submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1982 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.1850 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Accra Laboratories, Inc. devices

FDA 510(k) Submission Details - K821457

510(k) Number K821457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1982
Decision Date June 01, 1982
Days to Decision 15 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 113d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

IAF Device Classification - Class 1, General Controls

Product Code IAF Wright's Stain
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IAF Wright's Stain

All 18
Devices cleared under the same product code (IAF) and FDA review panel - the closest regulatory comparables to K821457.
HEMAQUIK II STAINING SOLUTION #55961
K830542 · Accra Laboratories, Inc. · Mar 1983
MIDAS 1000 WRIGHT STAIN #66010
K822980 · Emd Chemicals, Inc. · Oct 1982
MIDAS 1000 WRIGHT GIEMSA STAIN #66020
K822981 · Emd Chemicals, Inc. · Oct 1982
AVES WRIGHT STAIN
K820437 · Helena Laboratories · Mar 1982
ACCRA LAB HEMOTOLOGY
K812848 · Accra Laboratories, Inc. · Oct 1981
ACCRA LAB WRIGHT STAIN
K812504 · Accra Laboratories, Inc. · Sep 1981