Microscan Rapid Gram-Negative Indentification Type 3 Panel
FDA 510(k) K961042 · Dade Microscan, Inc.
510(k) numberK961042
Submission
- Device name
- Microscan Rapid Gram-Negative Indentification Type 3 Panel
- Applicant
- Dade Microscan, Inc.
West Sacramento, CA, US - Received
- March 14, 1996
- Decision date
- May 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRH – Instrument For Auto Reader Of Overnight Microorganism Identification System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code LRH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962609 | Gram Negative Identification Plus CardLRH · Traditional | Biomerieux Vitek, Inc. | 08/30/1996SE |
| K926248 | ReaderLRH · Traditional | Alamar Biosciences Laboratory, Inc. | 05/17/1994SE |
| K920225 | Autosceptor Identification SystemLRH · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/22/1992SE |
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Questions and answers
When was Microscan Rapid Gram-Negative Indentification Type 3 Panel cleared by the FDA?
Microscan Rapid Gram-Negative Indentification Type 3 Panel (K961042) received a 510(k) decision of Substantially Equivalent on May 30, 1996, 77 days after the submission was received.
What is the product code of K961042?
The FDA product code is LRH – Instrument For Auto Reader Of Overnight Microorganism Identification System, a Class I (low risk) device regulated under 21 CFR 866.2660.