510(k) K761170
- Device
- BARBITAL SALINE BUFFER
- Applicant
- Bio/Data Corp.
- 510(k) number
- K761170
- Product code
- JCE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-01-10
- Date received
- 1976-12-01
- Regulation
- 864.4010
- Classification name
- Solution, Isotonic
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2022807
- 1210083
- 3042896810
- 3009547954
- 3004857344
- 1625587
- 1831312
- 3008264111
- 3006365273
- 3005592623
- 3012314549
- 3010374920
- 1181121
- 3014257280
- 3013632692
- 3017830316
- 3004016977
- 3001106688
- 3008264242
- 3025413691
- 1125908
- 3017970519
- 3012309743
- 3015495690
- 3031180757
- 3015745029
- 3011715922
- 3005460813
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JCE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842722 | BUFFERED SALINE | E K Ind., Inc. | 1984-09-11 |
| K831200 | IMMUNOHEMATOLOGICAL SALINE #97139 | Emd Chemicals, Inc. | 1983-05-09 |
| K801506 | CERTIFIED BLOOD BANK SALINE | Nobel Scientific Industries, Inc. | 1980-07-28 |
| K792101 | COUITER/CMS ISOTONIC BLOOD BANK SALINE | Coulter Electronics, Inc. | 1979-11-20 |
| K761183 | LYSING AGENT AF | Central Labs. Assoc. MD Pathologists | 1977-01-17 |
| K761174 | PHYSIOLOGIC SALINE (0.85%) | Bio/Data Corp. | 1977-01-10 |