Atlas FDA

ELECYS IGE ASSAY

FDA 510(k) clearance K984326 · decided 1999-02-08

Clearance details

K-number
K984326
Device name
ELECYS IGE ASSAY
Applicant
Boehringer Mannheim Corp.
Decision
Substantially Equivalent
Date received
1998-12-03
Decision date
1999-02-08
Days to decision
67 days
Clearance type
Traditional
Product code
JHR
Device class
2
Regulation number
866.5510
Medical specialty
Immunology
Advisory committee
Immunology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ELECSYS IGE II IMMUNOASSAY (K061970)Roche Diagnostics2006-08-31
IMMILITE TOTAL IGE (K960067)Diagnostic Products Corp.1996-02-14
IMMULITE TOTAL IGE (K931703)Diagnostic Products Corp.1993-08-16
TURBO-RAST SPECIFIC IGE ASSAY (K903000)Ventrex Laboratories, Inc.1990-07-31
COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 (K901859)Diagnostic Products Corp.1990-05-03
ALTERNATE PROCEDURE, PHARMACIA IGE EIA (K882616)Pharmacia, Inc.1988-08-04
PHARMACIA IGE EIA (K873077)Pharmacia, Inc.1987-10-20
RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN (K840103)Techniclone Intl.1984-02-10

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ENZYMUN TEST{R} CEA (P860058/S001)Boehringer Mannheim Corp.1993-07-29
ENZYMUN-TEST{R} AFP (P860044/S003)Boehringer Mannheim Corp.1991-09-03
ENZYMUN-TEST{R} AFP (P860044/S002)Boehringer Mannheim Corp.1991-07-19
ENZYMUN-TEST{R} AFP (P860044/S001)Boehringer Mannheim Corp.1990-08-03
MICUR-MIC SYSTEMS (P820073)Boehringer Mannheim Corp.1983-06-29