Cleared Traditional

K780637 - HEMATOLOGY SLIDE STAINER

K780637 is an FDA 510(k) clearance for HEMATOLOGY SLIDE STAINER, manufactured by A. J. P. Scientific, Inc.. The device is a Class 1 Hematology device with product code KPA cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K780637 · A. J. P. Scientific, Inc. · Hematology device
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May 1978
Decision
32d
Days
Class 1
Risk

K780637 is an FDA 510(k) clearance for the HEMATOLOGY SLIDE STAINER. Classified as Slide Stainer, Automated (product code KPA), Class I - General Controls.

Submitted by A. J. P. Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 19, 1978 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.3800 - 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.

FDA 510(k) Submission Details - K780637

510(k) Number K780637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1978
Decision Date May 19, 1978
Days to Decision 32 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 113d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

KPA Device Classification - Class 1, General Controls

Product Code KPA Slide Stainer, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3800
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 - KPA Slide Stainer, Automated

All 20
Devices cleared under the same product code (KPA) and FDA review panel - the closest regulatory comparables to K780637.
MI DAS 1000 AUTOMATIC SLIDE STAINER
K821830 · Innovative Medical Systems, Inc. · Jul 1982
GUAMSTAINER
K811697 · Tomtec · Jul 1981
TECHNICON AUTOSLIDE STAINING/PROCESSING
K781598 · Technicon Instruments Corp. · Oct 1978
AUTO. SLIDE STAINER
K780017 · Honeywell, Inc. · Jan 1978
CARA-STAIN MODEL 3000
K771699 · American Safety Equipment Corp. · Sep 1977
HEMA-TEK II SLIDE STAINER
K771559 · Miles Laboratories, Inc. · Aug 1977
K780637 · HEMATOLOGY SLIDE STAINER
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