BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK— 510(k) K770076

Name: FDA 510(k) clearance K770076
Creator: U.S. Food and Drug Administration
Published: 1977-03-22

Substantially Equivalent

Jack W. Kindberg

FDA 510(k) clearance K770076 for BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK, Substantially Equivalent on 1977-03-22. Applicant: Jack W. Kindberg. Device class: 1.

Clearance details

Applicant: Jack W. Kindberg
Product code: Code KPA
Device class: Class 1
Regulation: 21 CFR 864.3800
Advisory panel: Pathology
Date received: 1977-01-13
Decision date: 1977-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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

More clearances from Jack W. Kindberg

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K770074 — BIO-DYES FORTIFIED HEMATOLOGY STAIN1977-03-22
K770075 — BIO-DYES HEMATOLOGY PHOSPHATE1977-03-22

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.