Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- FMHContainer, Specimen, Sterile1Product Code
- K900983TRI-TECH URINE SPECIMEN KIT1Cleared 510(K)
- K823763VARIOUS-SPECIMEN COLLECTORS1Cleared 510(K)
- K820180CALCULI FILTER CUP1Cleared 510(K)
- K812933LANCER SPECIMEN CONTAINER1Cleared 510(K)
- K802340SPECIMEN SET1Cleared 510(K)
- K802002URINE SPECIMEN CONTAINER #'S 1013-10161Cleared 510(K)
- K800947MIDSTREAM COLLECTION KIT1Cleared 510(K)
- K800309SPECIMEN COLLECTION PAN1Cleared 510(K)
- K800233ABCO MIDSTREAM URINE COLLECTION SET1Cleared 510(K)
- K792710PARA-PAK CLEAN VIAL1Cleared 510(K)
- K792156LANCER SPECIMEN CONTAINER1Cleared 510(K)
- K792211SPECIMAN CUP & EMESIS BASIN1Cleared 510(K)
- K790915JUHN TYM-TAP1Cleared 510(K)
- K790291OPERATING ROOM SPECIMEN CONTAINER1Cleared 510(K)
- K78155724-HOUR URINE COLLECTION COOLING WRAP1Cleared 510(K)
- K780167CATH KIT, URINE SPECIMEN1Cleared 510(K)
- K780057URINE SAMPLE COLLECTION KIT1Cleared 510(K)
- K780049SPECIMEN COLLECTION DEVICE1Cleared 510(K)
- K770387UNICATCH1Cleared 510(K)
- K770231MID-STREAM COLLECTION SET1Cleared 510(K)
- K770112SPECIMEN COLLECTOR1Cleared 510(K)
- K7611914 1/2 OZ. GRADUATED SPECIMEN CONTAINER1Cleared 510(K)
- K760496CUP, DISPOSABLE SPECIMEN1Cleared 510(K)
- NNIContainer, Specimen, Non-Sterile1Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
24-HOUR URINE COLLECTION COOLING WRAP
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K781557
- 510(k) Type
- Traditional
- Applicant
- SAGE PRODUCTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/17/1978
- Days to Decision
- 36 days