Para-Pak(Wheatley's Trichrome Stain)
FDA 510(k) K792706 · Meridian Diagnostics, Inc.
510(k) numberK792706
Submission
- Device name
- Para-Pak(Wheatley's Trichrome Stain)
- Applicant
- Meridian Diagnostics, Inc.
Mchenry, IL, US - Received
- December 27, 1979
- Decision date
- January 24, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HYW – Stain, Trichrome, Mallory'S
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code HYW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K781062 | Dropper, Solution Trichrome, Cepti-SealHYW · Traditional | Marion Laboratories, Inc. | 08/14/1978SE |
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| K982711 | Premier GiardiaMHI · Traditional | 11/25/1998SE |
| K980076 | Premier Platinum HpsaLYR · Traditional | 05/12/1998SE |
| K980077 | Para-Pak SpinconLKS · Traditional | 04/02/1998SE |
| K971585 | Immunocard Stat! RotavirusLIQ · Traditional | 08/20/1997SE |
Questions and answers
When was Para-Pak(Wheatley's Trichrome Stain) cleared by the FDA?
Para-Pak(Wheatley's Trichrome Stain) (K792706) received a 510(k) decision of Substantially Equivalent on January 24, 1980, 28 days after the submission was received.
What is the product code of K792706?
The FDA product code is HYW – Stain, Trichrome, Mallory'S, a Class I (low risk) device regulated under 21 CFR 864.1850.