Atlas FDA

ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM

FDA 510(k) clearance K930979 · decided 1993-09-08

Clearance details

K-number
K930979
Device name
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
Applicant
Boehringer Mannheim Corp.
Decision
Substantially Equivalent
Date received
1993-02-25
Decision date
1993-09-08
Days to decision
195 days
Clearance type
Traditional
Product code
CGA
Device class
2
Regulation number
862.1345
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ACCU-CHEK Advantage Blood Glucose Meter/ Blood Glucose Monitoring System; Cat. no. 870. Re recall (Z-1354-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage Complete Diabetes Monitoring Kit, Cat. No. 860. Ref. no. 080086000 wit recall (Z-1355-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 2137500; Ref. no. 0385633001 with meter recall (Z-1356-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 3332586; Ref. no. 03332586001 with meter recall (Z-1357-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both w recall (Z-1358-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Comfort Curve. Cat. No. 3149030; Ref. number 0314903001 with meter model number recall (Z-1359-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage (Managed Care Kit) 100- value memory with time and date, Not for Retai recall (Z-1360-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage (Conversion Kit),Cat. no. 3000338; Ref no. 03000338001 with meter mode recall (Z-1361-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage (Consignment kit), Cat. no. 3000320; catalog no. 03000320001 with mete recall (Z-1362-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage FPO Diabetes Monitoring Kit, Cat. no. 3271358001. Ref. no. 03271358001 recall (Z-1369-06)Roche Diagnostics Corp.2006-08-05

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