N/T Protein Control Sy/L, M and H
FDA 510(k) K952593 · Behring Diagnostics, Inc.
510(k) numberK952593
Submission
- Device name
- N/T Protein Control Sy/L, M and H
- Applicant
- Behring Diagnostics, Inc.
Westwood, MA, US - Received
- June 6, 1995
- Decision date
- July 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DAD – Haptoglobin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5460
- Specialty
- Immunology
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|---|---|---|---|
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| K972639 | Tina-Quant HaptoglobinDAD · Traditional | Boehringer Mannheim Corp. | 01/09/1998SE |
| K964301 | N-Assay Tia Multi V-NlDAD · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K963286 | Immage Immunochemistry System Haptoglobin (HPT) ReagentDAD · Traditional | Beckman Instruments, Inc. | 10/07/1996SE |
| K915829 | Il Test(Tm) Haptoglobin (HPT)DAD · Traditional | Instrumentation Laboratory CO | 07/29/1992SE |
| K911898 | Raichem(Tm) Spia(Tm) Haptoglobin ReagentDAD · Traditional | Reagents Applications, Inc. | 05/08/1991SE |
| K890562 | Spq(Tm) Antibody Reagent Set II for HPTDAD · Traditional | Atlantic Antibodies | 02/22/1989SE |
| K873866 | HaptoglobinDAD · Traditional | Unipath , Ltd. | 10/20/1987SE |
| K872717 | QM300 Haptoglobin Antibody PackDAD · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 07/21/1987SE |
| K864512 | Immuno-Plate IV Radial Immuno Test Kit/Human HaptoDAD · Traditional | Cooper Biomedical, Inc. | 02/13/1987SE |
More from Cooper Biomedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| 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 N/T Protein Control Sy/L, M and H cleared by the FDA?
N/T Protein Control Sy/L, M and H (K952593) received a 510(k) decision of Substantially Equivalent on July 17, 1995, 41 days after the submission was received.
What is the product code of K952593?
The FDA product code is DAD – Haptoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5460.