Accraassay Rid Kits
FDA 510(k) K761311 · Miles Laboratories, Inc.
510(k) numberK761311
Submission
- Device name
- Accraassay Rid Kits
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- December 23, 1976
- Decision date
- December 30, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JZQ – Plates And Equipment, Radial Immunodiffusion
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4800
- Specialty
- Immunology
Other 510(k)s with product code JZQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881174 | Rid Plate ReaderJZQ · Traditional | The Binding Site, Ltd. | 06/08/1988SE |
| K881675 | Immulon 4 Flat Bottom Plates & Removawell StripsJZQ · Traditional | Dynatech Laboratories, Inc. | 04/21/1988SE |
| K831811 | Revolution Radial Immunodiffusion PlateJZQ · Traditional | Calbiochem-Behring Corp. | 07/28/1983SE |
| K792699 | Ouchterlony Agar PlatesJZQ · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K790646 | Helena Quiplate SystemJZQ · Traditional | Helena Laboratories | 05/23/1979SE |
| K770548 | Immunoplate III Radio ImmunodiffusionJZQ · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 04/15/1977SE |
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| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
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| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Accraassay Rid Kits cleared by the FDA?
Accraassay Rid Kits (K761311) received a 510(k) decision of Substantially Equivalent on December 30, 1976, 7 days after the submission was received.
What is the product code of K761311?
The FDA product code is JZQ – Plates And Equipment, Radial Immunodiffusion, a Class I (low risk) device regulated under 21 CFR 866.4800.