HEMATOLOGY SLIDE STAINER— 510(k) K780637

Name: FDA 510(k) clearance K780637
Creator: U.S. Food and Drug Administration
Published: 1978-05-19

Substantially Equivalent

A. J. P. Scientific, Inc.

FDA 510(k) clearance K780637 for HEMATOLOGY SLIDE STAINER, Substantially Equivalent on 1978-05-19. Applicant: A. J. P. Scientific, Inc.. Device class: 1.

Clearance details

Applicant: A. J. P. Scientific, Inc.
Product code: Code KPA
Device class: Class 1
Regulation: 21 CFR 864.3800
Advisory panel: Pathology
Date received: 1978-04-17
Decision date: 1978-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPA

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K933996 — PROFIBLOT1994-01-28
K884258 — VERSABLOT1988-12-14
K881592 — WESCOR MODEL 7300 AEROSPRAY GRAM STAINER1988-05-13
K880745 — LX-100 SLIDE STAINER1988-04-27
K874887 — WESBLOT PROCESSOR1988-03-24

Adverse events under product code KPA

product code KPA

Malfunction: 1,177
Total: 1,177

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.