Company ยท US
Humagen Fertility Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2002. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 11, 2002 | K012811 | BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B Humagen Fertility Diagnostics, Inc. | MQH |
| May 12, 2000 | K000915 | PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 Humagen Fertility Diagnostics, Inc. | MQK |
| Jul 14, 1999 | K990941 | NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L Humagen Fertility Diagnostics, Inc. | MQK |
| Jul 14, 1999 | K990847 | INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M Humagen Fertility Diagnostics, Inc. | MQH |
| Aug 30, 1994 | K915229 | SEMEN ANALYSIS KIT Humagen Fertility Diagnostics, Inc. | POV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2007 | Humagen Fertility Diagnostics, Inc. IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagno Terminated |
MQK | K000915 |