Haemophilus Id Quad-Plate
FDA 510(k) K841304 · Gibco Laboratories Life Technologies, Inc.
510(k) numberK841304
Submission
- Device name
- Haemophilus Id Quad-Plate
- Applicant
- Gibco Laboratories Life Technologies, Inc.
Mchenry, IL, US - Received
- March 30, 1984
- Decision date
- April 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSI – Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
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| K864014 | Lombard Dowell Agar BaseKZI · Traditional | 10/29/1986SE |
| K863821 | Mueller Hinton Agar W/4%NACL and OxacillinJTZ · Traditional | 10/09/1986SE |
| K863820 | Dri-Form: Gbna Listeria Medium No. M22300JSJ · Traditional | 10/08/1986SE |
| K863289 | CDC Anaerobic Agar W/Sheep Blood, Kana-&VancomycinJSJ · Traditional | 09/03/1986SE |
| K862425 | Macconkey Agar W/Mug, Dri-Form and Pre-FormJSI · Traditional | 07/02/1986SE |
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Questions and answers
When was Haemophilus Id Quad-Plate cleared by the FDA?
Haemophilus Id Quad-Plate (K841304) received a 510(k) decision of Substantially Equivalent on April 17, 1984, 18 days after the submission was received.
What is the product code of K841304?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.