510(k) K842853

LYSINE IRON AGAR by Anarobe Systems — Product Code JSF

K842853 is an FDA 510(k) premarket notification submitted by Anarobe Systems for the device "LYSINE IRON AGAR". The FDA issued a decision of Substantially Equivalent on Aug 3, 1984. The device falls under product code JSF (Culture Media, Single Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Anarobe Systems has 6 other 510(k) clearances on record.

Clearance details

Decision: SESE (Substantially Equivalent)
Decision Date: Aug 3, 1984
Date Received: Jul 20, 1984
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device classification

Device Name: Culture Media, Single Biochemical Test
Device Class: Class I
Regulation Number: 866.2320
Review Panel: MI
Submission Type: 510(k) Exempt

Other clearances for product code JSF

K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T2860 (Apr 1, 1988)
K880120 — MOELLERS DECARBOXYLASE, LYSINE (Mar 31, 1988)
K880126 — LAURYL TRYPTOSE BROTH (Mar 31, 1988)
K880119 — MOELLERS DECARBOXYLASE, ONITHINE (Mar 31, 1988)
K880135 — NITRATE BROTH (Mar 30, 1988)
K880106 — ACETAMIDE AGAR SLANT (Mar 30, 1988)
K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (Mar 30, 1988)
K880129 — BRILLIANT GREEN BILE BROTH (Mar 30, 1988)
K880139 — ONPG TEST REAGENT (Mar 30, 1988)
K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (Mar 30, 1988)

510(k) K842853

Clearance details

Device classification

Other clearances by Anarobe Systems

Other clearances for product code JSF

FDA data resources