M. CAT BUTYRATE DISK— 510(k) K960996

Substantially Equivalent

Hardy Diagnostics

FDA 510(k) clearance K960996 for M. CAT BUTYRATE DISK, Substantially Equivalent on 1996-04-18. Applicant: Hardy Diagnostics. Device class: 1.

Clearance details

Applicant: Hardy Diagnostics
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1996-03-12
Decision date: 1996-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

Download summary PDF View on FDA.gov ↗

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K970833 — INDOLE SWAB1997-04-02
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Recalls naming K960996

K-number listed on FDA's recall record

Z-0554-2022 — HARDY DIAGNOSTICS CatScreen, 25dsk/vialClass II·Terminated·MEDLINE INDUSTRIES, LP - Northfield·20211201

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960996.

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