SABOURAUD DEXTROSE (SD) AGAR SLANT TUBE #T3080— 510(k) K873326

Name: FDA 510(k) clearance K873326
Creator: U.S. Food and Drug Administration
Published: 1987-10-02

Substantially Equivalent

Lakewood Biochemical Co., Inc.

FDA 510(k) clearance K873326 for SABOURAUD DEXTROSE (SD) AGAR SLANT TUBE #T3080, Substantially Equivalent on 1987-10-02. Applicant: Lakewood Biochemical Co., Inc.. Device class: 1.

Clearance details

Applicant: Lakewood Biochemical Co., Inc.
Product code: Code JSJ
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1987-08-18
Decision date: 1987-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSJ

view all

K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P34211988-06-22
K881524 — DERMATOPHYTE TEST MEDIUM1988-04-18
K881526 — CHAPMAN STONE MEDIUM1988-04-18
K881530 — BRILLIANT GREEN AGAR W/SULFADIAZINE1988-04-18
K881544 — LITTMAN AGAR1988-04-18

More clearances from Lakewood Biochemical Co., Inc.

view all

K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T30071988-07-01
K882351 — MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P341811988-06-28
K882182 — SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P33261988-06-06
K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T28601988-04-01
K880947 — NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE1988-04-01

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.