Cleared Traditional

K801357 - MODIFIED BLOOD CELL COUNTING & LYSING

K801357 is an FDA 510(k) clearance for MODIFIED BLOOD CELL COUNTING & LYSING, manufactured by Coulter Electronics, Inc.. The device is a Class 1 Hematology device with product code GIF cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K801357 · Coulter Electronics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1980
Decision
66d
Days
Class 1
Risk

K801357 is an FDA 510(k) clearance for the MODIFIED BLOOD CELL COUNTING & LYSING. Classified as Diluent, Blood Cell (product code GIF), Class I - General Controls.

Submitted by Coulter Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1980 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8200 - 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 Coulter Electronics, Inc. devices

FDA 510(k) Submission Details - K801357

510(k) Number K801357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1980
Decision Date August 14, 1980
Days to Decision 66 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
47d faster than avg
Panel avg: 113d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

GIF Device Classification - Class 1, General Controls

Product Code GIF Diluent, Blood Cell
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8200
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 - GIF Diluent, Blood Cell

All 18
Devices cleared under the same product code (GIF) and FDA review panel - the closest regulatory comparables to K801357.
UNITIZED HEMATOLOGY SET 65132/93
K840477 · Emd Chemicals, Inc. · Mar 1984
QUICK-COUNT HEMATOLOGY REAGENT KIT
K833972 · Seragen Diagnostics, Inc. · Feb 1984
REAGENT FOR COULTER COUNTER MODEL 5+11
K821683 · Fisher Scientific Co., LLC · Jun 1982
NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA
K801346 · Nobel Scientific Industries, Inc. · Aug 1980
DILUENT, CELLENT BLOOD
K790028 · Sysmex Corp. · Feb 1979
ISOTONIC DILUENT
K781008 · Mallinckrodt Critical Care · Jun 1978