Pathoplasma(R) I & II (Path Citrated Human Plasma)
FDA 510(k) K924401 · Behring Diagnostics, Inc.
510(k) numberK924401
Submission
- Device name
- Pathoplasma(R) I & II (Path Citrated Human Plasma)
- Applicant
- Behring Diagnostics, Inc.
Westwood, MA, US - Received
- August 31, 1992
- Decision date
- February 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGC – Control, Plasma, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
Other 510(k)s with product code GGC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102552 | Hemosil la Positive ControlGGC · Traditional | Instrumentation Laboratory CO | 04/05/2011SE |
| K100103 | Specialty Assayed CONTROL-2GGC · Traditional | Helena Laboratories | 12/15/2010SE |
| K062306 | Plasmacon N, Plasmacon L-1, Plasmacon L-2GGC · Traditional | R2 Diagnostics, Inc. | 03/16/2007SE |
| K061803 | Sta - Control la 1+2GGC · Traditional | Diagnostica Stago, Inc. | 07/28/2006SE |
| K032804 | Cryocheck Weak Lupus Positive ControlGGC · Traditional | Precision Biologic | 11/03/2003SE |
| K023312 | Control Plasma PGGC · Traditional | Dade Behring, Inc. | 11/01/2002SE |
| K020878 | Lyphochek Hemostasis, Models 798, 799GGC · Traditional | Bio-Rad | 04/15/2002SE |
| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | Sigma Diagnostics, Inc. | 02/06/2002SE |
| K012422 | K-Assay D-Dimer ControlsGGC · Traditional | Kamiya Biomedical Co. | 08/21/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | Sigma Diagnostics, Inc. | 03/01/2001SE |
More from Sigma Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973832 | Opus HLH ControlsJJX · Traditional | 10/27/1997SE |
| K972929 | N Antiserum to Human AlbuminDCF · Traditional | 10/20/1997SE |
| K972840 | N Antiserum to Human TransferrinDDG · Traditional | 10/17/1997SE |
| K973202 | Modification of Opus Ferritin Test SystemDBF · Traditional | 09/12/1997SE |
| K972316 | Opus D-DimerGHH · Traditional | 09/09/1997SE |
| K972116 | Von Willebrand ReagentGGP · Traditional | 07/25/1997SE |
| K972011 | Opus EthanolDIC · Traditional | 07/22/1997SE |
| K971600 | Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)DKB · Traditional | 06/25/1997SE |
| K971596 | Emit II Opiates 300/2000 AssayDJG · Traditional | 06/25/1997SE |
| K964595 | Opus Psa Test SystemLTJ · Traditional | 06/24/1997SE |
Questions and answers
When was Pathoplasma(R) I & II (Path Citrated Human Plasma) cleared by the FDA?
Pathoplasma(R) I & II (Path Citrated Human Plasma) (K924401) received a 510(k) decision of Substantially Equivalent on February 22, 1994, 540 days after the submission was received.
What is the product code of K924401?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.