510(k) K993715
- Device
- QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3
- Applicant
- SERACARE TECHNOLOGY
- 510(k) number
- K993715
- Product code
- JJT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-11-16
- Date received
- 1999-11-03
- Regulation
- 862.1660
- Classification name
- Enzyme Controls (assayed And Unassayed)
- Medical specialty
- Clinical Chemistry
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUSTY SEWELL
- Address
- 2170 Woodward St. Austin TX US 78744 78744
FDA Registration Numbers#
- 2032900
- 2027969
- 2085085
- 9610746
- 3011325031
- 3050015
- 1221645
- 2016706
- 9610126
- 1618982
- 3005333358
- 3010127294
- 3012240236
- 3004493545
- 8043909
- 2085064
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JJT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K090940 | SPOTCHECK BLOOD SPOT CONTROL, ASSAYED | Astoria-Pacific, Inc. | 2009-12-14 |
| K062751 | MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER | Quantimetrix Corp. | 2006-10-03 |
| K030768 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL | Cliniqa Corporation | 2003-03-21 |
| K030102 | ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 | Bayer Healthcare, LLC | 2003-01-24 |
| K021498 | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL | Bio-Rad | 2002-05-24 |
| K012656 | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 | Bio-Rad | 2001-09-06 |
| K993723 | CARDIASURE CARDIAC MARKERS CONTROL | Quantimetrix Corp. | 1999-11-23 |
| K992430 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | Medical Analysis Systems, Inc. | 1999-08-30 |
| K984437 | QUANTEX ASO-CRP-RP CONTROL II | Instrumentation Laboratory CO | 1999-02-02 |
| K984277 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | Medical Analysis Systems, Inc. | 1998-12-09 |
| K982845 | CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 | More Diagnostics | 1998-08-21 |
| K980556 | LIQUICHEK CARDIAC MARKERS CONTROL LT | Bio-Rad | 1998-02-25 |
| K974461 | TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL | Biosite Incorporated | 1997-12-10 |
| K973974 | DADE TRU-LIQUID CARDIAC CONTROL | Dade Intl., Inc. | 1997-11-06 |
| K972976 | CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL | More Diagnostics | 1997-08-29 |
Legacy Summary#
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FDA Review#
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