CRYOPETTE
Labware, Assisted Reproduction
MID-ATLANTIC DIAGNOSTICS, INC.
The following data is part of a premarket notification filed by Mid-atlantic Diagnostics, Inc. with the FDA for Cryopette.
Pre-market Notification Details
| Device ID | K100596 |
| 510k Number | K100596 |
| Device Name: | CRYOPETTE |
| Classification | Labware, Assisted Reproduction |
| Applicant | MID-ATLANTIC DIAGNOSTICS, INC. 18905 CELEBRITY LANE Sandy Spring, MD 20860 |
| Contact | Elisa D Harvey |
| Correspondent | Elisa D Harvey MID-ATLANTIC DIAGNOSTICS, INC. 18905 CELEBRITY LANE Sandy Spring, MD 20860 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-02 |
| Decision Date | 2010-12-06 |
| Summary: | summary |
Trademark Results [CRYOPETTE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRYOPETTE 77155349 not registered Dead/Abandoned |
Drummond Scientific Company 2007-04-12 |
 CRYOPETTE 77154740 3377481 Dead/Cancelled |
ORIGIO INC. 2007-04-12 |
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