510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Metrika, Inc.

Sunnyvale, CA, US

Metrika, Inc. appears in FDA device records in Sunnyvale, CA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 11 510(k) clearances for Metrika, Inc. between 1999 and 2005. The busiest year on record is 1999, with 4. The most recent is 2005, with 1.

Clearances by year, as a table
510(k) clearance decisions for Metrika, Inc., by decision year
YearClearances
19994
20002
20023
20031
20051
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K051321INVIEWLCPSubstantially Equivalent
K033847A1CNOW FOR HOME AND PROFESSIONAL USELCPSubstantially Equivalent
K022661A1CNOW FOR HOME USELCPSubstantially Equivalent
K020235A1CNOW FOR PROFESSIONAL USELCPSubstantially Equivalent
K020234A1CNOW FOR RX HOME USELCPSubstantially Equivalent
K000885DRX HBA1C - FOR PRESCRIPTION HOME USELCPSubstantially Equivalent
K000887DRX HBA1CLCPSubstantially Equivalent
K992997OSTEOMARK NTX POCJMMSubstantially Equivalent
K991532DRX QT. HCGDHASubstantially Equivalent
K984530DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSEJFYSubstantially Equivalent
K991917OSTEOMARK NTX POINT OF CARE (POC) CONTROL SETJJWSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0289-2008A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA 94085. (This test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is used by professional healthcare providers to monitor long-term glycemic control in people with diabetes. The product is sold as a kit with a disposable monitor and reagents for ten A1C tests and is suitable for use at the point-of-care.Incorrect Test Results: Due to manufacturing errors regarding temperature compensation factors, the device will give erroneously high results if the test is performed below 70 degrees Fahrenheit.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain