Immunochemistry Sys. Manual Mode
FDA 510(k) K781006 · Beckman Instruments, Inc.
510(k) numberK781006
Submission
- Device name
- Immunochemistry Sys. Manual Mode
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- June 19, 1978
- Decision date
- August 31, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JZW – Nephelometer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4540
- Specialty
- Immunology
Other 510(k)s with product code JZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001647 | BN Prospec SystemJZW · Traditional | Dade Behring, Inc. | 09/26/2000SE |
| K761234 | Behring Laser NephelometerJZW · Traditional | Behring Diagnostics, Inc. | 06/07/1990SE |
| K892223 | Behring Nephelometer 100JZW · Traditional | Behring Diagnostics, Inc. | 05/04/1989SE |
| K873407 | RRT System Laser Reflectometer AnalyzerJZW · Traditional | Incstar Corp. | 09/23/1987SE |
| K873401 | TurboxJZW · Traditional | Unipath , Ltd. | 09/23/1987SE |
| K801949 | BCM-302 Collimating Cone & CompensatinJZW · Traditional | B C Medical , Ltd. | 10/03/1980SE |
| K801391 | Disc 120 TransporterJZW · Traditional | Travenol Laboratories, S.A. | 07/14/1980SE |
| K792014 | Lancer L-Ina Buffer, Polymer, Wash SoluJZW · Traditional | Sherwood Medical Industries | 11/13/1979SE |
| K761236 | Antiserum Human (Pro.) Nephelometric Gr.JZW · Traditional | Behring Diagnostics, Inc. | 12/30/1976SE |
| K761235 | Laser Standard SerumJZW · Traditional | Behring Diagnostics, Inc. | 12/30/1976SE |
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|---|---|---|
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| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
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Questions and answers
When was Immunochemistry Sys. Manual Mode cleared by the FDA?
Immunochemistry Sys. Manual Mode (K781006) received a 510(k) decision of Substantially Equivalent on August 31, 1978, 73 days after the submission was received.
What is the product code of K781006?
The FDA product code is JZW – Nephelometer, a Class I (low risk) device regulated under 21 CFR 866.4540.