510(k) K893971
- Device
- ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II
- Applicant
- ANALYTICAL CONTROL SYSTEMS, INC.
- 510(k) number
- K893971
- Product code
- GGC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-07-25
- Date received
- 1989-06-02
- Regulation
- 864.5425
- Classification name
- Control, Plasma, Abnormal
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAULINE BONDERMAN
- Address
- 9001 Technology Dr. Suite A Fishers IN US 46060 46060
FDA Registration Numbers#
- 9710666
- 3004737529
- 1721937
- 3014150341
- 3003691680
- 2431530
- 1928890
- 8043599
- 1181121
- 3004434070
- 3037000637
- 1000340866
- 9610806
- 3016938816
- 1835316
- 1618982
- 2245451
- 3008386529
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GGC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102552 | HEMOSIL LA POSITIVE CONTROL | Instrumentation Laboratory CO | 2011-04-05 |
| K100103 | SPECIALTY ASSAYED CONTROL-2 | Helena Laboratories | 2010-12-15 |
| K062306 | PLASMACON N, PLASMACON L-1, PLASMACON L-2 | R2 Diagnostics, Inc. | 2007-03-16 |
| K061803 | STA - CONTROL LA 1+2 | Diagnostica Stago, Inc. | 2006-07-28 |
| K032804 | CRYOCHECK WEAK LUPUS POSITIVE CONTROL | Precision Biologic | 2003-11-03 |
| K023312 | CONTROL PLASMA P | Dade Behring, Inc. | 2002-11-01 |
| K020878 | LYPHOCHEK HEMOSTASIS, MODELS 798, 799 | Bio-Rad | 2002-04-15 |
| K020109 | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL | Sigma Diagnostics, Inc. | 2002-02-06 |
| K012422 | K-ASSAY D-DIMER CONTROLS | Kamiya Biomedical Co. | 2001-08-21 |
| K003329 | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | Sigma Diagnostics, Inc. | 2001-03-01 |
| K993332 | GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 | Gradipore , Ltd. | 2000-02-16 |
| K984131 | COAGULATION CONTROL LEVEL 3 (ABNORMAL) | Pacific Hemostasis | 1998-12-01 |
| K984130 | COAGULATION CONTROL LEVEL 2 (ABNORMAL) | Pacific Hemostasis | 1998-12-01 |
| K961370 | LA POSITIVE CONTROL PLASMA | Medical Diagnostic Technologies, Inc. | 1996-05-24 |
| K955040 | AT-III CONTROL PLASMA KIT | American Bioproducts Co. | 1996-01-31 |
Legacy Summary#
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FDA Review#
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