510(k) K941737
- Device
- SPECIALTY ASSAYED CONTROL-1
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K941737
- Product code
- GIZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-10-07
- Date received
- 1994-04-07
- Regulation
- 864.5425
- Classification name
- Plasma, Control, Normal
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAT FRANKS
- Address
- 1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704
FDA Registration Numbers#
- 1721937
- 8043599
- 1928890
- 3037000637
- 1000340866
- 3014150341
- 1835316
- 2431530
- 1618982
- 3003691680
- 9710666
- 3013660430
- 9610806
- 2245451
- 1181121
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GIZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060968 | STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW | Wortham Laboratories, Inc. | 2007-05-15 |
| K042941 | DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS | Dade Behring, Inc. | 2004-12-02 |
| K023309 | CONTROL PLASMA N | Dade Behring, Inc. | 2002-11-01 |
| K013708 | REFERENCE CHECK, CATALOG NUMBER-RCN-10 | Precision Biologic | 2001-12-10 |
| K003328 | ACCUCLOT CONTROL I, MODEL A4089 | Sigma Diagnostics, Inc. | 2001-03-01 |
| K001256 | CONTROL PLASMA N | Dade Behring, Inc. | 2000-05-24 |
| K984129 | COAGULATION CONTROL LEVEL 1 (NORMAL) | Pacific Hemostasis | 1998-12-01 |
| K973274 | ACCUCOLOR HIGH CALIBRATOR (A3089) | Sigma Diagnostics, Inc. | 1997-10-31 |
| K961814 | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS | Cardiovascular Diagnostics, Inc. | 1996-08-13 |
| K935254 | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA | American Diagnostica, Inc. | 1994-09-19 |
| K924403 | CONTROL PLASMA N | Behring Diagnostics, Inc. | 1994-02-22 |
| K932145 | COAGULATION REFERENCE PLASMA, NORMAL | American Diagnostic Corp. | 1993-10-18 |
| K922021 | UNICALIBRATOR KIT | American Bioproducts Co. | 1992-06-09 |
| K905203 | COAGULATION REFERENCE PLASMA, NORMAL | Medical Diagnostic Technologies, Inc. | 1990-12-28 |
| K895262 | NORMAL COAGULATION CONTROL PLASMA (NCCP) | Medical Diagnostic Technologies, Inc. | 1989-10-06 |
Legacy Summary#
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FDA Review#
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