BIOTIS SXT AGAR— 510(k) K862399

Name: FDA 510(k) clearance K862399
Creator: U.S. Food and Drug Administration
Published: 1986-07-03

Substantially Equivalent

Otisville Biotech, Inc.

FDA 510(k) clearance K862399 for BIOTIS SXT AGAR, Substantially Equivalent on 1986-07-03. Applicant: Otisville Biotech, Inc.. Device class: 1.

Clearance details

Applicant: Otisville Biotech, Inc.
Product code: Code JSJ
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1986-06-24
Decision date: 1986-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otisville, NY, US

Download summary PDF View on FDA.gov ↗

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K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P34211988-06-22
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K881526 — CHAPMAN STONE MEDIUM1988-04-18
K881530 — BRILLIANT GREEN AGAR W/SULFADIAZINE1988-04-18
K881544 — LITTMAN AGAR1988-04-18

More clearances from Otisville Biotech, Inc.

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K862387 — BIOTIS HAEMOPHILUS IDENTIFICATION QUAD1986-07-03
K862388 — BIOTIS TCBS AGAR1986-07-03
K862389 — BIOTIS ACETAMIDE AGAR1986-07-03
K862390 — BIOTIS BORDET GENGOU AGAR1986-07-03
K862391 — BIOTIS DESOXYCHOLATE AGAR1986-07-03

Adverse events under product code JSJ

product code JSJ

Malfunction: 520
Total: 520

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.