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510(k) K850722

Device
Martin Lewis Agar
Applicant
RAPID CITY REGIONAL HOSPITAL, INC.
510(k) number
K850722
Product code
JTY
Decision
Substantially Equivalent (SESE)
Decision date
1985-03-22
Date received
1985-02-22
Regulation
866.2410
Classification name
Culture Media, For Isolation Of Pathogenic Neisseria
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SHEILA M HILLBERRY
Address
353 Fairmont Blvd. Rapid City SD US 57701 57701

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JTY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K210511InTray GCBiomed Diagnostics Incorporated2021-10-20
K993033INTRAY GCBiomed Diagnostics, Inc.1999-12-16
K954986GC BASE W/ 1% GCHIRemel, L.P.1996-02-16
K950196CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIABioclinical Systems, Inc.1995-06-30
K933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARBioclinical Systems, Inc.1994-02-09
K933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARBioclinical Systems, Inc.1994-02-03
K934331THAYER MARTIN, MODIFIED PILL POCKETHardy Diagnostics1993-12-21
K934330TRANSGROWHardy Diagnostics1993-12-17
K931864MARTIN LEWIS WITH LINOCMYCINHardy Diagnostics1993-12-15
K881552PROTEOSE NO. 3 AGARAcumedia Manufacturers, Inc.1988-04-18
K881527CASMAN MEDIUM BASEAcumedia Manufacturers, Inc.1988-04-18
K871541MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226Gibco Laboratories Life Technologies, Inc.1987-04-29
K864253THAYER MARTIN AGARMds Laboratories, Inc.1987-03-31
K864252THAYER-MARTIN JEMBECMds Laboratories, Inc.1987-03-31
K864803GC-LECT(TM)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-02-03